sedating a child

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Sedating a child

If your child has any of these symptoms, call the Dental Clinic at immediately. If you are calling during the evening or on a weekend, please call the hospital at and ask for the dental resident on call. It is important to notify us in advance about any special needs your child might have. Children's Hospital's main campus is located in the Lawrenceville neighborhood.

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To pay your bill online, please visit UPMC's online bill payment system. Support the hospital by making a donation online , joining our Heroes in Healing monthly donor program , or visiting our site to learn about the other ways you can give back. Our Sites. Pediatric Dentistry. Sedation is the use of medication to make your child very calm for a procedure, but not sound asleep. There may be some restrictions when your child goes home.

What is Sedation Dentistry? Sedation dentistry is the use of a mild sedative calming drugs to manage special needs or anxiety while your child receives dental care. Home Preparation When sedation is needed, there are important rules for eating and drinking that must be followed in the hours before the procedure. For infants under 12 months: Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse.

For all children: After midnight the night before the procedure, do not give any solid food or non-clear liquids. That includes milk, formula, juices with pulp, coffee, and chewing gum or candy. Up to 2 hours before the scheduled arrival time, give only clear liquids. Milk is not a clear liquid. Sedation medication may be given by mouth, through the nose, or directly into a vein through an intravenous IV line.

The medicine will work in one of two ways — in a single dose that takes effect slowly and lasts throughout the procedure, or in a continuous dose throughout the procedure. You may stay with your child until he or she is very drowsy. How To Comfort Your Child Before Induction As a parent, watching your child undergo sedation may be a very uncomfortable experience for you. There are ways you can help your child, even if you feel uncomfortable. You can touch your child to remind your child that you are there.

You can whisper, talk, or sing to your child. The sound of your voice can provide reassurance. Following Sedation When the procedure is done, you will be called to the room to be with your child as the medication wears off. The length of time it will take the medication to wear off will vary, as some children take longer than others to become alert. Children coming out of sedation react in different ways. Your child might cry, be fussy or confused, feel sick to his or her stomach, or vomit.

There were no placebo controlled trials identified. Twelve RCTs met the inclusion criteria for the review of the efficacy of nitrous oxide. Meta-analysis were performed if comparisons and outcome measures were sufficiently homogenous to calculate a meaningful summary statistic , , Nitrous oxide vs. EMLA; Ekbom Three non RCT observational studies assessed the safety of nitrous oxide in a total of 8, patients. Two prospective cohort studies with greater than subjects specifically assessed the safety of nitrous oxide 21 , One systematic review which contained information from two relevant paediatric RCTs was also included The non RCT study characteristics for nitrous oxide are presented in Table The non RCT adverse event table for nitrous oxide are presented in Table Nitrous oxide Non RCT study characteristics.

Safety review. Nitrous oxide safety: Non RCT. Two studies by the same authors with similar research methods and outcomes were meta-analysed. Anxiety was the only outcome of interest measured in this study. Behavioural observations were made using the Venham clinical rating scale. The GDG noted that most of the evidence for nitrous oxide came from studies of painful procedures in the Emergency Department or the Dental clinic settings.

The evidence level was low except in one RCT where the level was moderate. The GDG agreed that both the efficacy and safety may be dependent on the concentration of nitrous oxide used. The GDG noted that the evidence of efficacy in the RCTs was limited to the successful outcome of the procedure and that there were no data to allow the quality of the sedation to be assessed.

The GDG recognised that nitrous oxide is very widely used in UK dental clinics and it was appreciated that the success of administration of nitrous oxide relies on ability of the patient to breathe the gas continuously via a mask placed over the mouth and nose, or over the nose for dental procedures.

Gaining and maintaining cooperation of a patient also relies on the skill of the healthcare practitioners. In small uncooperative children nitrous oxide was not found to be any more effective than oxygen alone but in cooperative children nitrous oxide could be used for a wide range of painful procedures provided the analgesia of the nitrous oxide was sufficient.

In the dental setting the injection of local anaesthesia can be uncomfortable and the analgesia from nitrous oxide is effective for the local anaesthesia; thereafter, the value of nitrous oxide may relate to its euphoric and anxiolytic effect. Nevertheless it was argued by the dentists on the GDG that these studies were in children who had been referred to a dental clinic that specialised in the management of anxious children. In other dental clinics, where children may be less anxious, the success rate was considered to be much higher although no direct evidence was available to support this.

The advantages of nitrous oxide were considered to be that it was well tolerated and short acting and highly effective in selected patient groups and settings. Occasionally it causes dysphoria and vomiting but this may be related to higher concentrations of nitrous oxide. The GDG appreciated the potential economic advantages of nitrous oxide successfully delivered in the dental clinic setting rather than anaesthesia in the dental hospital setting.

The GDG considered the safety of nitrous oxide. Equipment failure and medical contraindications to the use of nitrous oxide are rare but the GDG agreed that patients must be assessed and that practitioners must be trained to use nitrous oxide safely. The GDG agreed that nitrous oxide used alone had a good tolerability record and that fasting was not required although nitrous oxide may induce vomiting if the stomach was full and that it could be safely administered by the dentist who was treating the patient.

The GDG debated the merits of combining nitrous oxide with other drugs to increase its efficacy. In that study the combination of drugs did not cause unconsciousness but the GDG discussed the risk of unconsciousness caused by combining drugs. It was appreciated that intravenous and inhalational drugs could be titrated to achieve conscious sedation and that unconsciousness was extremely unlikely provided the dental sedation team were skilled. Nevertheless it was agreed that there was a risk of unintended unconsciousness and that only specially trained dental sedation teams should use combinations of sedation drugs to achieve sedation.

The GDG agreed that airway management skills and equipment are essential for combining nitrous oxide with other sedation drugs. The GDG agreed that nitrous oxide alone, and nitrous oxide combined with other drugs nitrous oxide plus sevoflurane, nitrous oxide plus sevoflurane plus midazolam, and nitrous oxide plus midazolam are commonly used in dental procedures in children, and that there is some evidence that they are effective and well tolerated.

It was therefore agreed that these strategies should be included in the economic analysis. Details of the considerations of cost- effectiveness with respect to using these strategies in dental procedure in children are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is sevoflurane or isoflurane with or without: analgesia, another drug or psychological techniques :. The literature was searched for systematic reviews and RCTs for the clinical efficacy of sevoflurane or isoflurane.

The search was expanded to include non RCT observational studies for the safety of sevoflurane or isoflurane. There were no systematic reviews identified for the use of sevoflurane or isoflurane in paediatric sedation. Two RCTs comparing sevoflurane in any route with other sedative drugs were assessed for efficacy and safety.

One non RCT observational study in patients assessed the safety of sevoflurane. There were no relevant studies conducted in children that assessed the safety and efficacy of sedation with isoflurane. For the characteristics of studies and outcome data refer to Table 65 and Table One study 51 reported rates of:. Three studies 20 , 51 , informed the GDG discussion on sevoflurane. Sevoflurane is an anaesthetic agent and the GDG discussed whether there was an appreciable risk of accidental anaesthesia.

Two 20 , of the three studies were RCTs in which sevoflurane had been used to sedate anxious children for dental procedures in a specialist dental clinic. The GDG appreciated that sevoflurane was being used in a similar fashion to nitrous oxide in that it required the patient to tolerate breathing the vapour via a nasal mask.

In low doses sevoflurane was reported to not cause anaesthesia and its success therefore relied on a degree of cooperation of the patient. The dental studies were in anxious children up to the age of Concentrations of up to 0. The addition of sevoflurane was found to increase the completion rate of dental treatment. The GDG agreed that this is a successful technique but that it required special expertise of a trained sedation team , and that airway management skills and equipment are essential for this drug in this setting.

The other study 51 considered was a descriptive account of infants who were sedated by a combination of sevoflurane and nitrous oxide for painless imaging. The dose of sevoflurane used was 1. The GDG discussed the advantages of sevoflurane sedation over sevoflurane anaesthesia. In certain settings, in which the patient needs to cooperate with a procedure, such as a dental procedure, sedation may be appropriate.

In other situations, such as painless imaging where an uncooperative child needs to be immobile and asleep, the dose of sevoflurane required to cause sleep is likely to cause anaesthesia. The GDG agreed that it was safer to assume that that patients were anaesthetised in this setting and that they would therefore need to managed as though they had a short acting anaesthetic rather than sedation.

Overall the GDG agreed that sevoflurane should only be used by specially trained sedation teams, including a doctor trained in paediatric anaesthesia. The GDG agreed that only sedation techniques commonly available in the NHS should be included in the economic analysis.

Sevoflurane combined with other drugs sevoflurane plus nitrous oxide, sevoflurane plus nitrous oxide plus midazolam were felt to be strategies commonly used in dental procedures in children. There is evidence that these drug combinations are effective and well tolerated.

The GDG therefore agreed that they should be included in the economic analysis. Details of the considerations of cost- effectiveness with respect to using these combination strategies in dental procedures in children are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is propofol with or without: analgesia, another drug or psychological techniques :. The literature was searched for systematic reviews and RCTs for the clinical efficacy of propofol.

The search was expanded to include non- RCT observational studies for the safety of propofol. There were no systematic reviews identified for the use of propofol in paediatric sedation. One RCT comparing intravenous propofol with other sedative drug was assessed for efficacy and safety. Seven non-RCTs observational studies in 64, patients assessed the safety of intravenous propofol. For the characteristics of studies and outcome data on propofol refer to Table 68 and Table In one study 46 it was unclear whether sedation was used for sedation or anaesthesia and how much dose of the propofol was administered.

Propofol, being a short acting intravenous anaesthetic agent , can be titrated to achieve any target level of sedation and anaesthesia. The true level of sedation was often not stated. The GDG appreciated that the difference between sedative and anaesthesia doses was small and that unintentional anaesthesia was a risk with this drug.

It was noted that doses necessary to cause sedation may depend upon the procedure. For example the dose required for a painless procedure would be less than for a painful procedure. The GDG noted that the dose of propofol required for a painful procedure maybe reduced by the use of analgesia and in this respect the combination of an opioid with propofol may reduce the doses of both drugs.

Seven studies , , , were considered by the GDG very low level evidence. The studies involved procedures ranging from painless imaging, painful ED procedures and endoscopy. The target sedation level was deep or not stated. The GDG considered the doses used and agreed that many of the children would have been anesthetised at some stage. The safety of propofol was discussed. The GDG agreed that tracheal intubation would occasionally be required and that propofol should only be used by teams who had adequate training to manage anaesthesia.

The GDG noted that propofol was used in two studies 24 , 25 for children undergoing endoscopy. Propofol was being used without any airway device and the GDG agreed that practitioners would need special training to ensure that the airway was not obstructed by the insertion of the endoscope. The GDG believed that laryngospasm was an appreciable risk during this procedure and that sedation teams would need the skills and judgement to manage it.

The GDG discussed the use of a technique combining propofol with other sedation drugs such as midazolam, ketamine and opioids. The GDG understood that combinations of these drugs are being used to provide sedation for dental procedures in the UK.

No RCTs were found testing the combinations of these drugs and therefore the efficacy could not be assessed. The GDG thought that such a technique could cause unintentional deep and prolonged sedation. While it is true that the effects of opioid and midazolam can be reversed by naloxone and flumazenil, the reversal requires prompt administration and sedation may outlast the effects of reversal agent s. In contrast to drug combinations, the GDG agreed that unconsciousness and airway effects are more likely with propofol, but are brief.

Recovery of full consciousness after propofol is much more rapid and airway obstruction or apnoea can be managed with appropriate skills and equipment. The GDG discussed the potential economic advantages of using propofol to either sedate or anaesthetise children for a wide variety of procedures.

In comparison with almost any other method of sedation , propofol was the most effective apart from ketamine and sevoflurane. Provided intravenous access could be achieved propofol had the advantages of speedy onset and recovery. Propofol could enable a faster turnover of patients than many techniques.

The disadvantage however is that propofol would need the same staff and facilities as an anaesthetic. Propofol combined with fentanyl was felt to be a strategy commonly used in short painful procedures, and there is some evidence from the systematic review of opioids that propofol plus fentanyl is an effective and safe strategy. The GDG therefore agreed that the combination strategy should be compared to other relevant strategies in the economic analysis conducted for this population group.

Details of the considerations of cost- effectiveness with respect to using propofol plus fentanyl in short painful procedures are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is intravenous morphine, intravenous fentanyl or intranasal diamorphine with or without: analgesia, another drug or psychological techniques :.

The literature was searched for systematic reviews and RCTs for the clinical efficacy of opioids intravenous morphine, intravenous fentanyl or intranasal diamorphine. The search was expanded to include non RCT observational studies for the safety of opioids. There were no systematic reviews identified for the use of opioids in paediatric sedation.

Five RCTs comparing intravenous morphine, intravenous fentanyl, and intranasal diamorphine with other sedative drugs were assessed for efficacy and safety. Five non RCT observational studies in 2, patients assessed the safety of opioids , , , , There were four prospective studies, and one retrospective study conducted for the following procedures: imaging procedures 1 , accidents and emergencies procedures 3 as well for GI procedures 1. The non RCT study characteristics for opioids are presented in Table The non RCT adverse event table for opioids is presented in Table Possible sources of heterogeneity could be attributed to the differences between the studies in procedure performed catheter insertion versus orthopaedic fracture or joint reduction and length of procedure orthopaedic fracture or joint reduction takes longer , setting inpatients versus accidents and emergencies and varying dose of combination agents.

For the characteristics of studies and outcome data refer to Table 76 and Table The GDG found no studies that opioids morphine, fentanyl and diamorphine were effective for any diagnostic or therapeutic procedure when used alone to cause sedation rather than simply analgesia. In the studies found, opioids were always combined with other drugs and the GDG agreed that they had been used for their analgesic properties within a sedation technique.

The sedative potential of these selected opioids could not be determined from the evidence. There was one RCT of morphine in which it was combined with midazolam in the Emergency department setting. The efficacy of this combination could not be determined from the data because the evidence level was very low. The GDG agreed that morphine was a drug that had an analgesic action that was much longer than most painful procedures and for this reason shorter acting opioids such as fentanyl were likely to be more suitable.

All other evidence on opioids was provided from studies of combinations of fentanyl with either midazolam or propofol. Most studies were in the emergency department setting but one was in a hospital in children undergoing lumbar puncture. The GDG agreed that the principles of sedation for painful procedures in the ED were applicable to sedation for similar painful procedures in other settings.

The choice of opioid to be used in combination with midazolam was debated. In the early discussions of the GDG it was agreed that evidence for pethidine would not be sought because it had a longer action than fentanyl and because it was not widely used. The combination of fentanyl with midazolam was used with the intention of maintaining moderate sedation but the GDG appreciated that it was sometimes difficult to titrate the drugs to provide sedation and analgesia to overcome the pain of the procedure without causing deep sedation or appreciable suppression of airway reflexes or breathing.

The hazard of opioid induced respiratory depression occurring after the procedure had been completed was noted by the GDG. In comparison, ketamine has a safer record and has a similar induction and recovery time. The GDG agreed that even with careful titration of fentanyl and midazolam, deep sedation and airway obstruction or apnoea are possible and that this combination should only be used by a trained sedation team.

Airway management skills and equipment are essential for this drug combination. Fentanyl combined with propofol was considered by the GDG to be a useful deep sedation or anaesthesia technique. Two RCTs 38 , 56 were considered. One showed that the addition of fentanyl to propofol reduced recovery time and the other found that propofol doses could be reduced. Fentanyl was associated with fewer adverse events.

A combination of fentanyl and midazolam was felt to be commonly used in colonoscopy and short painful procedures for example, reduction of a dislocated joint , whereas fentanyl plus propofol was felt to be commonly used in short painful procedures.

There is some evidence that these combination strategies are effective and well tolerated. Details of the considerations of cost- effectiveness with respect to using fentanyl plus propofol in short painful procedures, and using fentanyl plus midazolam in colonoscopy are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, does a combination of psychological techniques and sedation drugs lead to sedation sparing?

The literature was searched for systematic reviews and RCTs for sedation sparing i. There were no systematic reviews, RCTs or observational studies that reported relevant outcome measures for analyses of our efficacy and safety outcomes. There were no RCTs or observational studies relevant for analyses of our efficacy and safety outcomes.

The GDG felt that sedation sparing techniques are not among the sedation techniques commonly used in the NHS, and decided that an economic analysis should not be done for these techniques. There are different types of diagnostic and therapeutic procedures. For example, some procedures are painful yet others are painless but require prolonged immobility. The efficacy and safety of sedation depends therefore not only on the drug or technique but also on the procedure itself.

After reviewing the drugs, the GDG sought to group the evidence according to the type of procedure to enable the development of guidance on effective and well tolerated sedation for specific procedures. There are many types of procedures and the GDG accepted that guidance on each and every procedure was not practicable. For the purposes of this guidance, the GDG used the classifications of.

Guidance for uncommon procedures can be obtained by applying relevant principles from the guidance below. Before considering sedation for a procedure the practitioner will need to understand what the procedure entails, what is expected of the patient, and what the sedation technique needs to achieve see chapter 4. Many children will be able to tolerate painless diagnostic imaging tests without sedation drugs. Adequate patient preparation, parental involvement, and a child-friendly environment are important for success see section 4.

Non-pharmacological methods such as play therapy and distraction techniques may be also helpful for children who are able to co-operate. The majority of children of school age will manage well with these techniques as an alternative to sedation. Highly anxious children may be helped by having anxiolytic drugs. However there are a large number of children who are too ill, in pain or have behavioural problems that prevent them lying still for prolonged imaging. The target level of sedation will vary according to the imaging procedure.

CT scans and echocardiography can be done under moderate sedation. Some children may need to be asleep in order to tolerate complex or prolonged investigations. Examples include MRI and nuclear medicine imaging that may involve the child keeping still for up to an hour. MRI can be particularly frightening because it is noisy and involves lying still in an enclosed space. The level of sedation achieved while the patient is asleep is uncertain; they may be moderately sedated and sleeping naturally, be deeply sedated or be anaesthetised.

Determining the level of sedation relies on stimulating the patient which may spoil the image. Not all children will sleep with these drugs. Anaesthesia, by comparison is always effective and short acting. Low doses of anaesthetic agents also cause sedation of uncertain depth however the true depth may be estimated from the drug dose. The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 77 and Table 78 below. The tabular presentation was developed as a way to summarise disparate data, ranging across various drug types, drug combinations, specialty areas and procedural techniques.

The tables have thus been organised by setting and include the following: painless procedures imaging , dentistry, painful procedures and GI procedures. The primary efficacy outcome was completion of procedure. GDG judgment on drugs safety and efficacy in painless procedures. GDG judgment on combination drugs safety and efficacy in painless procedures. On the basis of the evidence , the GDG made a decision regarding the efficacy and safety benefits and harms of each drug and drug combination reviewed.

They indicated their decision in the tables below. The economic evidence for this group was obtained by modelling the treatment pathway for high dose chloral hydrate and comparing this with general anaesthesia see Appendix F on cost-effectiveness analysis. This was informed by evidence from clinical and safety review as well as GDG expert opinion.

High dose chloral hydrate was more costly than general anaesthesia because this type of sedation was assumed to be less successful but also to require the same staff levels as general anaesthesia. In cases where the addition of a sedationist physician is required, as with chloral hydrate, sedation could still be cost saving compared to general anaesthesia but this will depend primarily on:.

Of all the imaging techniques MRI is the most common scenario in which sedation may be needed. MRI usually lasts between 30 and 60 minutes and CT imaging is much shorter. To be still enough, the patient usually needs to be sleeping, and the true target level of sedation is uncertain; it may be moderate, deep or anaesthesia. The GDG agreed that the ideal sedation method should not cause sedation much longer than the scan itself.

For this reason, techniques such as propofol or sevoflurane have advantages of fast induction time, certainty of completion, and rapid recovery. Many children presenting for imaging are uncooperative because they are young, they have a behavioural problem or because they are distressed or in pain. A further advantage of propofol or sevofluorane is that they can be used in all age groups and all types of patients.

Infants who sleep after a feed may lie still enough without any sedation. Also, many children can be calmed sufficiently and persuaded to lie still without the use of sedation. Occasionally an anxiolytic drug may help them but only if they are cooperative.

Children who are uncooperative need sedation or anaesthesia. The GDG considered that sedation with Chloral hydrate was an effective and well tolerated alternative to anaesthesia but only in children less than 15kg. The success rate of chloral hydrate may be maximised by careful patient assessment and selection. The GDG recognised that chloral hydrate may not always be effective and that intravenous midazolam is a drug commonly used to either increase the depth of sedation or prolong sedation.

Chloral hydrate causes sleep lasting approximately one hour and is therefore less appropriate for scans lasting a few minutes. An advantage of chloral is that it does not require the services of an anaesthesia team. Midazolam was shown to be one of the most cost-effective sedation techniques for dental procedures 6. Other types of painless imaging such as trans-thoracic echocardiography or EEG do not require the child to be completely immobile and they may therefore be managed with minimal or moderate sedation.

Anaesthesia would not be appropriate for these investigations either because the risks outweigh the benefits in patients with cardiac problems or, in the case of EEG, anaesthesia may suppress the EEG signal under investigation. Many children undergo brief painful procedures following injury such as suture of lacerations and orthopaedic manipulations in emergency departments. In a recent review 19 the prompt administration of analgesia has been promoted not only because it is important and compassionate, but because it can reduce anxiety and increase cooperation of the child or young person to enable the procedure to be carried out with sedation rather than anaesthesia.

If the patient is unable to cooperate local anaesthesia is still important because the dose of sedative drug can be minimized if the patient has no pain. The following recommendations in this section are applicable to any painful procedure not only in the emergency setting but elsewhere such as a hospital ward. There are several potentially useful sedation techniques for painful procedures. The decision to undertake a particular technique should be influenced by factors such as the type and duration of a painful procedure, the age and developmental stage of the child, and the urgency of a painful procedure.

In particular, clinicians should consider the target depth of sedation required, and the relative requirement for analgesia, sedation, immobility and amnesia. Prolonged or complex procedures should be carried out under general anaesthesia. The sedation techniques recommended for painful procedures are considered in relation to the three target levels of sedation although it should be appreciated that there is variation in the sedation level achieved.

Ketamine induces sedation which has different characteristics to any other sedation drug. Ketamine tends to preserve airway reflexes, spontaneous respiration, and cardiovascular stability. Nevertheless occasionally ketamine can cause airway complications including laryngospasm. Dissociative sedation has been included in the category of deep sedation because the training and facilities needed for safe practice are similar see sections 4.

However ketamine is considered to have a wider margin of safety than other anaesthetic agents, although practitioners must be able to manage the potential complication of laryngospasm; after an initial normal blood pressure measurement, repeat blood pressure measurements are generally required only if other vital signs are abnormal and otherwise may be intrusive particularly when using sub-dissociative doses.

Wound suture and foreign body removal are common examples of painful procedures usually carried out under minimal sedation. Moderate sedation is required for brief emergency orthopaedic procedures such as transferring a child with a fractured limb or placing the limb into a splint and reduction of a dislocated joint. Titration of the drugs used to achieve moderate sedation is important to avoid excessive respiratory depression.

Examples of procedures usually carried out under dissociative or deep sedation are suture of lacerations to the face and nail bed in young children, and orthopaedic manipulations. In an urgent or emergency situation the time of the last food and drink intake in children and young people is often uncertain. Moreover, trauma may delay gastric emptying. The problem of whether to use sedation or anaesthesia within a few hours after admission to hospital in a patient who may not be fasted is common.

In most situations the procedure can be delayed although there will be practical problems of arranging for the procedure later. The risk of pulmonary aspiration during deep sedation and anaesthesia will need to be balanced with the risk of delaying the procedure. In many situations it may be reasonable to use a sedation technique with a wide margin of safety in a patient who is not fasted see section 4. This has arisen because anaesthesia services are not always available. Skills necessary for safe sedation can be achieved by practitioners who are not fully trained anaesthetists see section 4.

The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 79 and Table 80 below. GDG judgment on drugs safety and efficacy in painful procedures. GDG judgment on combination drugs safety and efficacy in painful procedures. On the basis of the evidence , the GDG considered the efficacy and safety benefits and harms of each drug and drug combination reviewed. They indicated their decision for each drug in the tables below.

The economic evidence for this group was obtained by modelling the treatment pathway for two sedative drugs ketamine and a combination of fentanyl plus propofol and comparing these with general anaesthesia see Appendix F on cost-effectiveness analysis. Sedation drugs were shown to be cost-saving compared to general anaesthesia , and ketamine was less costly than fentanyl plus propofol. However, we would be cautious about concluding that any one sedation technique is the lowest cost for all patients, since in extremely anxious patients minimal to moderate sedation will fail and the cost of a rescheduled procedure will be incurred.

Therefore, careful patient selection should lead to a more effective and more cost-effective service. Management of minor trauma in the ED is the most common scenario for brief painful procedures but the principles of effective and well tolerated sedation in the ED can be applied to other areas such as hospital wards.

Sedation may be used to make possible injection of local anaesthetic, which in turn may be sedation sparing. If local anaesthesia was not practical or appropriate, analgesia by another method would be necessary. Nitrous oxide is potentially effective for cooperative patients but for many children either an opioid or ketamine would be necessary. Opioids are not effective alone and need to be combined with midazolam or propofol.

They should be used with caution because they cause respiratory depression especially after the pain of a procedure has abated. Airway obstruction is a potential complication in this situation, and airway management skills are a requirement for the practitioner.

Ketamine, in contrast, is effective without any other drug and tends to maintain vital reflexes. Moreover it can be given intramuscularly if venous access is difficult and it is applicable to infants and children. The GDG agreed that ketamine sedation had many advantages and that it was a well tolerated technique provided teams were trained to use it safely and competent to manage potential complications.

The main debate was whether ketamine sedation , delivered by an ED team, would have economic advantages over anaesthesia, delivered by an anaesthesia team the day after the trauma. The GDG considered that this was a common and realistic scenario and that guidance on this issue would help healthcare provider manage resources efficiently. Economic modelling showed ketamine to be lower cost than either propofol or general anaesthesia for forearm fracture.

We did not model minimal sedation for this group but for dental procedures either nitrous oxide or midazolam were shown to be the lowest cost sedation techniques 6. The provision of adequate anxiety control is an integral part of the practice of dentistry. The General Dental Council GDC has indicated that this is both a right for the patient and a duty placed on the dentist Child dental anxiety is widespread Many anxious children can be satisfactorily treated using relative analgesia RA , this combines behaviour management techniques with inhaled nitrous oxide and oxygen.

RA is the mainstay of paediatric dental sedation but this approach is unsuccessful in some children In such cases, control of pain and anxiety poses a significant barrier to dental care and a dental general anaesthetic DGA is often seen as the only option. However, DGA carries its own risks and dental treatment provided under DGA also tends to be more radical, with a greater proportion of extractions than fillings Since there has been a sea-change in the provision of pain and anxiety management in dentistry in the UK.

This has resulted in an increased emphasis on the safe provision of conscious sedation instead of a reliance on general anaesthesia. General anaesthesia should be provided only in response to clinical need. In , DGA was prohibited in non-hospital settings in England.

The vast majority of dental treatment is carried out in a primary care setting. All children deserve appropriate anxiety control for any dental procedure. The method of anxiety control should be individually selected for each patient. A range of sedation techniques is required; each technique ensuring a wide margin of safety between conscious sedation and the unconscious state provided by general anaesthesia 9 , , This NICE guidance both builds on and is consistent with existing guidance for dentistry.

The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 81 and Table 82 below. GDG judgment on drugs safety and efficacy in dental procedures. GDG judgment on combination drugs safety and efficacy in dental procedures. The economic evidence for dental procedures in children was obtained by modelling the treatment pathway for a tooth extraction for four sedation drugs evaluated to be well tolerated and efficacious in the previous section.

Nitrous oxide plus oxygen, nitrous oxide plus midazolam, sevoflurane plus nitrous oxide, sevoflurane plus nitrous oxide plus midazolam were compared with general anaesthesia see Appendix F on cost-effectiveness analysis. For adolescents we modelled the treatment pathway for a tooth extraction using midazolam compared with general anaesthesia. Nitrous oxide plus oxygen with or without iv midazolam are likely to be the two lowest cost strategies for tooth extraction in children.

Midazolam was less expensive than general anaesthesia for tooth extraction in adolescents. So careful patient selection should lead to a more effective and more cost-effective service. In general, the cost of the drugs is less important than the cost of the staff involved. We found that sedation is clearly cost-saving compared to general anaesthesia in cases where the operating dentist is able to administer sedation without the addition of a sedationist dentist, typically for minimal to moderate sedation.

In this case, quite a low success rate is required for sedation to be cost-saving. In cases where the addition of a sedationist dentist is required typically for deeper conscious sedation , sedation could still be cost saving compared with general anaesthesia but this will depend primarily on. A published case study has shown that in one district in the North East of England, the charges associated with sedation strategies in primary dental care were likely to be substantially lower than the equivalent charge for the same procedure conducted under GA Many children currently require both dental extractions and conservative treatment and many are too anxious to allow the insertion of local anaesthesia.

Sedation for dentistry requires that the patient opens their mouth and therefore they need to remain conscious. Moderate sedation maintaining verbal contact conscious sedation with intravenous midazolam, is considered to be effective for selected children and young people who are cooperative, and younger children who can tolerate a nasal mask can be managed with nitrous oxide.

In the past, if these were not effective, anaesthesia has often been the only alternative. The GDG agreed that additional sedation techniques could be effective for patients who cannot be managed by midazolam or nitrous oxide. If demand is high, alternative sedation techniques would be necessary.

The common concern is that additional sedation drugs, especially in combination, may not be predictable enough for widespread use. Sevoflurane and propofol for example may only be safe enough for use by specialist sedation teams. The GDG agreed that there were potential important economic advantages of avoiding hospital based anaesthesia services. Economic modelling showed midazolam or nitrous oxide to be the lowest cost strategies in suitably selected patients.

The training of dental sedation teams was regarded as crucial. Gastrointestinal GI endoscopy procedures are commonly required in children and young people. The procedures consist of upper GI endoscopy often called oesophago-gastro duodenoscopy [OGD] or gastroscopy and lower GI endoscopy colonoscopy. In children and young people the majority of procedures are diagnostic; however, there are some therapeutic techniques performed for example oesophageal dilatation and polypectomy that make the procedure more technically difficult and time consuming.

Upper endoscopy is uncomfortable but not usually painful. The target level of sedation during upper endoscopy is considered to be no deeper than moderate sedation. The child or young person will need to maintain their airway reflexes for an OGD because vomiting and regurgitation are common. Moreover the endoscope itself may obstruct the airway in an unconscious patient. Colonoscopy may be uncomfortable but can be tolerated by many children and young people under moderate sedation. The use of an analgesic drug is often necessary.

If sedation is not successful, anaesthesia should be used and in many centres anaesthesia is the only method used. Recently, anaesthesia agents have been used to sedate to the target level that the patient needs in order to tolerate the procedure. This is usually deep sedation but in most cases the patient is anaesthetized albeit for a brief period. Such a method does not necessarily require tracheal intubation and allows effective short acting sedation.

Whoever administers anaesthetic agents must be trained to manage the complications of airway obstruction and respiratory depression see section 4. The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 83 and 85 below. They indicated their decision in Table 83 and GDG judgment on combination drugs safety and efficacy in endoscopy. The economic evidence for oesophago-gastroscopy was obtained by modelling the treatment pathway for midazolam and comparing it with general anaesthesia see Appendix F on cost-effectiveness analysis.

The economic evidence for colonoscopy was obtained by also modelling the treatment pathway for midazolam plus fentanyl and comparing this combination with general anaesthesia. Midazolam was shown to be less expensive than general anaesthesia in oesophago-gastroscopy, and in colonoscopy, the combination sedation strategy, midazolam plus fentanyl, was less expensive than general anaesthesia. Gastroenterological endoscopy is uncomfortable. Gastroscopy requires control of pharyngeal and oesophageal reflexes to overcome retching.

Colonoscopy may need opioid analgesia. The GDG felt that a large proportion of children and young people requiring these procedures were old enough to be cooperative and that moderate sedation was effective. It was agreed that deep sedation was potentially hazardous if it was administered by untrained practitioners and without safe resources. The choice of opioid to be used in combination with midazolam combination of midazolam was debated. In the early discussions of the GDG it was agreed that evidence for pethidine would not be sought primarily because it had a longer action than fentanyl but also because it was not widely used.

In respect of endoscopy however the GDG was advised by one of its members that pethidine may be in common use for colonoscopy. Training in the use of any new technique was considered to be crucial. It was agreed that moderate sedation may not always be effective enough and that sometimes sedation may have to be abandoned. Patient assessment and selection will be important to minimise sedation failure.

Occasionally sedation can become too deep and this results in prolonged recovery. The GDG agreed that whenever moderate sedation is ineffective a short acting titratable drug such as propofol was ideal. Propofol however readily causes unconsciousness and the hazard of pulmonary aspiration is a special concern with this technique. Staff training and facilities for anaesthesia will be necessary for propofol based techniques.

If an anaesthesia team is available either sevoflurane or propofol can be used to induce deep sedation or anaesthesia and this can be applied to children of all ages undergoing procedures of variable length. Tracheal intubation may be needed for gastroscopy and this can be readily achieved by an anaesthesia team. Economic modelling showed midazolam with fentanyl in the case of colonoscopy to be lower cost than general anaesthesia for endoscopy.

The GDG agreed that there were potentially important economic advantages of using propofol rather than moderate sedation and that this should be considered by healthcare providers. Midazolam has a strong safety profile in inducing either minimal or moderate sedation.

For painful procedures midazolam should be combined with analgesia. Ideally analgesia is achieved by local anaesthesia. Sometimes local analgesia is insufficient and potent opioid analgesia is necessary. The combination of potent opioid and midazolam can cause deep sedation and airway obstruction. These effects can be managed safely but involve extra resources. It would be safer if a technique could be developed that was both reliable and had a wide margin of safety.

Prospective and retrospective audit data are available to help guide the choice of opioid and the doses. A randomised controlled trial is needed to test the efficacy and safety of these combinations. Ketamine is demonstrated to have a strong efficacy and safety profile in enabling safe sedation and as an analgesic drug useful for painful procedures in children and young people.

No data is available on whether antiemetic drugs prevent vomiting. It generally requires admission to hospital; it may be more expensive and is a scarce resource. Data comparing the efficiency of sedation in comparison with anaesthesia for certain procedures are not available. Models of care need to be developed and studied to whether anaesthesia or sedation gives the best value for money. With such data, efficient services can be planned. Propofol is a short acting anaesthetic agent that can be used to achieve any target sedation level.

The dose necessary for gastrointestinal endoscopy however usually has a tendency to cause anaesthesia albeit for a short period of time. It would be helpful to know the dose limitation that is unlikely to cause deep sedation because this dose may be effective and well tolerated enough. Moderate sedation with propofol could be compared with another sedation technique such as midazolam with or without opioid. It could also be compared with a general anaesthetic dose of propofol.

Both ketamine and propofol are well tolerated and effective drugs suitable for painful procedures. Propofol however has a tendency to cause deep sedation and anaesthesia in which the airway and breathing may need an intervention or support. Ketamine has few appreciable effects on the airway and breathing but has a longer recovery time than propofol and causes vomiting. There are no data on the safety of sedation in the UK. A large prospective database of sedation cases, that includes data on drugs, procedures, the depth of sedation and complications, would help to define the safety of sedation and also actively promote safe practice.

The GDG suggests that a national registry for paediatric sedation is established to help create a database with sufficient data. Propofol in low dose is an excellent anxiolytic. Patient-controlled sedation has been validated in adults undergoing dental procedures and endoscopy for safety and efficacy. Giving the patient control of their sedation has important psychological benefits. The study would involve developing new pump technology, paediatric software and a child friendly patient-activation system.

There would have to be an open pilot evaluation to establish safety and efficacy followed by a randomised-controlled trial versus IV midazolam. As stated in the study. It was not possible to calculate the point estimate for this outcome based on the information reported in the study. Ketamine is a dissociative agent: the state of dissociative sedation cannot be readily categorised as either moderate or deep sedation ; the drug is considered to have a wide margin of safety.

At the time of publication December the BNFc stipulated that if deep sedation is needed an anaesthetic agent propofol or ketamine , or a potent opioid fentanyl may be used. However, they should be used only under the supervision of a specialist experienced in the use of these drugs. Chloral hydrate is used in UK clinical practice for sedating children and young people for painless procedures.

At the time of publication December chloral hydrate did not have UK marketing authorisation for this indication. See appendix J. Midazolam is used in UK clinical practice for sedating all children and young people up to the age of At the time of publication December midazolam did not have UK marketing authorisation for children younger than 6 months or for oral or buccal administration. Propofol is used in UK clinical practice for sedation of children and young people.

At the time of publication December propofol did not have UK marketing authorisation for this age group. Sevoflurane is used in UK clinical practice for sedating children and young people. At the time of publication December sevoflurane did not have UK marketing authorisation for this indication.

Midazolam is used in UK clinical practice for sedating children and young people up to the age of At the time of publication December midazolam did not have UK marketing authorisation for oral or buccal administration or for children younger than 6 months. Propofol is used in UK clinical practice for sedating children and young people. At the time of publication December midazolam did not have UK marketing authorisation for oral or buccal administration, or for children younger than 6 months.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, , no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK.

Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page. The use of registered names, trademarks, etc. The rights of National Clinical Guideline Centre to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, Turn recording back on.

National Center for Biotechnology Information , U. Search term. General clinical introduction: drugs for sedation in infants, children and young people The Guideline Development Group GDG considered that many potentially useful sedation drugs could be reviewed.

Placebo ; non-pharmacological treatment. Combination including analgesia and general anaesthesia. General methodological introduction: drugs for sedation in infants, children and young people Efficacy outcome data for this review was taken from RCTs alone.

The outcome measures for drug efficacy that were considered by the GDG were as follows: Primary outcome Successful completion of diagnostic or therapeutic procedure. Secondary outcomes Behavioural ratings including:. Sedation timing including. Respiratory intervention , including:. Clinical methodological introduction for midazolam CLINICAL QUESTIONS For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is midazolam with or without: analgesia, another drug or psychological techniques : - effective for sedation at minimal, moderate, and deep levels in comparison with usual care, with analgesia alone, with another sedation drug, with psychological techniques or with general anaesthesia?

Evidence profiles for midazolam 6. RCT evidence profiles for efficacy and safety for midazolam Study characteristics and methodological quality of the study are provided in Appendix D. Evidence statements for midazolam 6. Duration of procedure [the study stated that and time to discharge were not significant data was not shown ]. Respiratory intervention [moderate quality evidence ]. Vomiting during procedure and recovery [moderate quality evidence ].

Completion of procedure [moderate quality evidence ]. The level of anxiety Herbertt-Michaelinnees-Venham scale [moderate quality evidence ]. Oral midazolam plus non-pharmacological vs. Shorter duration of procedure [very low quality evidence ]. Patients' preference [very low quality evidence ].

Pain assessment It was not possible to calculate the point estimate for this outcome based on the data provided. Pain assessed by parents VAS [low quality evidence ]. Pain assessed by patients VAS [low quality evidence ]. Vomiting after discharge [low quality evidence ]. Shorted induction time [low quality evidence ]. Faster recovery time [low quality evidence ]. Longer total time [low quality evidence ]. Less vomiting [low quality evidence ]. Completion of procedure [very low quality evidence ].

Duration of procedure [low quality evidence ]. Enteral midazolam vs. Vomiting during drug nitrous oxide administration [moderate quality evidence ]. Induction time [low quality evidence ]. Duration of procedure [very low quality evidence ]. Aspiration [moderate quality evidence ]. Vomiting during visit during procedure and after the last suture was placed [low quality evidence ]. IV propofol Disma 56 All patients completed the endoscopy procedure [moderate quality evidence ].

The duration of procedure [moderate quality evidence ]. The recovery time [low quality evidence ]. Assisted ventilation bag-mask [low quality evidence ]. Slower recovery time [low quality evidence ]. Aspiration [low quality evidence ].

Assisted ventilation [low quality evidence ]. Endotracheal intubation [low quality evidence ]. Pain number of patients [very low quality evidence ]. IV fentanyl analgesic Antmen 16 All patients completed the procedure [low quality evidence ].

Vomiting [low quality evidence ]. Pain VAS [very low quality evidence ]. Assisted ventilation bag mask [low evidence quality]. More satisfied parents [low quality evidence ]. Recovery time [very low quality evidence ].

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If your child experiences any of the following for more than 24 hours, you should call your dentist:. If your child has any of these symptoms, call the Dental Clinic at immediately. If you are calling during the evening or on a weekend, please call the hospital at and ask for the dental resident on call.

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Our Sites. Pediatric Dentistry. Sedation is the use of medication to make your child very calm for a procedure, but not sound asleep. There may be some restrictions when your child goes home. What is Sedation Dentistry? Sedation dentistry is the use of a mild sedative calming drugs to manage special needs or anxiety while your child receives dental care.

Home Preparation When sedation is needed, there are important rules for eating and drinking that must be followed in the hours before the procedure. For infants under 12 months: Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. For all children: After midnight the night before the procedure, do not give any solid food or non-clear liquids. That includes milk, formula, juices with pulp, coffee, and chewing gum or candy.

Up to 2 hours before the scheduled arrival time, give only clear liquids. Milk is not a clear liquid. Sedation medication may be given by mouth, through the nose, or directly into a vein through an intravenous IV line. The medicine will work in one of two ways — in a single dose that takes effect slowly and lasts throughout the procedure, or in a continuous dose throughout the procedure. You may stay with your child until he or she is very drowsy.

How To Comfort Your Child Before Induction As a parent, watching your child undergo sedation may be a very uncomfortable experience for you. There are ways you can help your child, even if you feel uncomfortable. You can touch your child to remind your child that you are there. You can whisper, talk, or sing to your child.

The sound of your voice can provide reassurance. Following Sedation When the procedure is done, you will be called to the room to be with your child as the medication wears off. The length of time it will take the medication to wear off will vary, as some children take longer than others to become alert. Children coming out of sedation react in different ways. The GDG agreed that chloral hydrate is therefore likely to be less successful in larger children. Some GDG members thought more than 1g of chloral hydrate may be vomited and hence be unsuccessful.

This may explain why choral is thought to be more effective in smaller children. The GDG considered 14 studies 43 , 49 , 69 , 83 , 84 , 92 , 97 , , , , , , , of chloral hydrate used alone; two others 96 , were of chloral hydrate combined with other drugs. Ten of these studies were in children undergoing painless procedures; five for dental treatment 49 , 96 , 97 , , and one for ophthalmic examination Of the painless procedure studies, five were for MRI 43 , 84 , , , and two for CT imaging 83 , Two RCTs , were found for painless imaging.

One study showed that high dose chloral hydrate was not more effective than low dose for MRI but that high dose chloral hydrate caused shorter onset of sedation the evidence level was moderate. The other study showed that anaesthesia was more effective than chloral hydrate for CT imaging the evidence level was low.

The other studies were non- RCT. High doses were likely to be more reliable than low doses. The GDG debated as to what sedation level was achieved by chloral hydrate in the painless imaging setting. The GDG noted that the doses of chloral hydrate used caused the children to sleep and, because the success of the scanning required them to be immobile and undisturbed, the true sedation level achieved was uncertain. The GDG members appreciated that all children in the evidence studies were likely to be either moderately or deeply sedated.

Nevertheless the GDG agreed that unconsciousness was possible and that appreciable airway and breathing effects could be caused in a small percentage of children. These problems were uncommon but were reported. In one cohort study 83 a child with severe mental retardation suffered pulmonary aspiration during sedation. The disadvantages of chloral hydrate are that it is administered as a single oral dose, that it cannot therefore be titrated, and that its effect is variable in terms of depth of sedation , and its onset and recovery times.

However there are potential economic advantages of chloral hydrate if its success rate is high enough because anaesthesia resources may be saved both techniques are equally safe. There was evidence of chloral hydrate being used in other settings. Chloral hydrate combined with nitrous oxide was shown in one study 96 to be more effective than nitrous oxide alone in young children having dental treatment.

Chloral hydrate was also useful for calming small irritable children for echocardiography and in this setting the GDG appreciated that anaesthesia would not usually be appropriate. The GDG noted that small children could be sedated successfully with chloral hydrate for eye examination.

In another study the GDG noted that children could be calmed for EEG studies more effectively by music rather than chloral hydrate however the GDG thought that this was an unusual setting and that children having EEG are not required to be immobile. Chloral hydrate was felt to be effective and safe. It is commonly used in painless imaging in the NHS. The GDG therefore agreed that this strategy should be included in the economic analysis conducted for patients undergoing painless imaging.

Details of the considerations of cost- effectiveness with respect to using chloral hydrate in painless imaging are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is triclofos sodium with or without: analgesia, another drug or psychological techniques :. Effective for sedation at minimal, moderate, and deep levels in comparison with usual care, with analgesia alone, with another sedation drug, with psychological techniques or with general anaesthesia?

Safe for sedation at mild, moderate, and deep levels in different settings? The literature was searched for systematic reviews RCTs for the clinical efficacy of triclofos sodium. The search was expanded to include non RCT observational studies for the safety of triclofos sodium. There were no systematic reviews identified for the use of triclofos sodium in paediatric sedation. One RCT was found that compared triclofos sodium with midazolam. Whilst efficacy data was reported safety data was not.

There were no non-RCT observational studies assessing the safety of triclofos sodium. Meta-analyses were not performed as there was only one RCT. Oral triclofos sodium vs. There were no non RCT observational studies of triclofos sodium. Only one study of triclofos was found and it compared triclofos with midazolam for dental procedures.

The GDG noted that triclofos was not effective in this setting and also that the quality of evidence was very low. The GDG noted that the properties of triclofos and chloral hydrate were similar and that triclofos may cause less gastric irritation. The GDG discussed the potential advantages of triclofos but without evidence this drug could not be recommended as more effective than chloral hydrate.

The GDG felt that triclofos sodium is not among the sedation drugs commonly used in the NHS, and decided that it should not be included in the economic analysis. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is nitrous oxide with or without: analgesia, another drug or psychological techniques :. The literature was searched for systematic reviews and RCTs for the clinical efficacy and safety of nitrous oxide.

The search was expanded to include observational studies for the safety of nitrous oxide. No systematic reviews were identified for the use of nitrous oxide in paediatric sedation. There were no placebo controlled trials identified.

Twelve RCTs met the inclusion criteria for the review of the efficacy of nitrous oxide. Meta-analysis were performed if comparisons and outcome measures were sufficiently homogenous to calculate a meaningful summary statistic , , Nitrous oxide vs.

EMLA; Ekbom Three non RCT observational studies assessed the safety of nitrous oxide in a total of 8, patients. Two prospective cohort studies with greater than subjects specifically assessed the safety of nitrous oxide 21 , One systematic review which contained information from two relevant paediatric RCTs was also included The non RCT study characteristics for nitrous oxide are presented in Table The non RCT adverse event table for nitrous oxide are presented in Table Nitrous oxide Non RCT study characteristics.

Safety review. Nitrous oxide safety: Non RCT. Two studies by the same authors with similar research methods and outcomes were meta-analysed. Anxiety was the only outcome of interest measured in this study. Behavioural observations were made using the Venham clinical rating scale. The GDG noted that most of the evidence for nitrous oxide came from studies of painful procedures in the Emergency Department or the Dental clinic settings.

The evidence level was low except in one RCT where the level was moderate. The GDG agreed that both the efficacy and safety may be dependent on the concentration of nitrous oxide used. The GDG noted that the evidence of efficacy in the RCTs was limited to the successful outcome of the procedure and that there were no data to allow the quality of the sedation to be assessed. The GDG recognised that nitrous oxide is very widely used in UK dental clinics and it was appreciated that the success of administration of nitrous oxide relies on ability of the patient to breathe the gas continuously via a mask placed over the mouth and nose, or over the nose for dental procedures.

Gaining and maintaining cooperation of a patient also relies on the skill of the healthcare practitioners. In small uncooperative children nitrous oxide was not found to be any more effective than oxygen alone but in cooperative children nitrous oxide could be used for a wide range of painful procedures provided the analgesia of the nitrous oxide was sufficient. In the dental setting the injection of local anaesthesia can be uncomfortable and the analgesia from nitrous oxide is effective for the local anaesthesia; thereafter, the value of nitrous oxide may relate to its euphoric and anxiolytic effect.

Nevertheless it was argued by the dentists on the GDG that these studies were in children who had been referred to a dental clinic that specialised in the management of anxious children. In other dental clinics, where children may be less anxious, the success rate was considered to be much higher although no direct evidence was available to support this. The advantages of nitrous oxide were considered to be that it was well tolerated and short acting and highly effective in selected patient groups and settings.

Occasionally it causes dysphoria and vomiting but this may be related to higher concentrations of nitrous oxide. The GDG appreciated the potential economic advantages of nitrous oxide successfully delivered in the dental clinic setting rather than anaesthesia in the dental hospital setting.

The GDG considered the safety of nitrous oxide. Equipment failure and medical contraindications to the use of nitrous oxide are rare but the GDG agreed that patients must be assessed and that practitioners must be trained to use nitrous oxide safely. The GDG agreed that nitrous oxide used alone had a good tolerability record and that fasting was not required although nitrous oxide may induce vomiting if the stomach was full and that it could be safely administered by the dentist who was treating the patient.

The GDG debated the merits of combining nitrous oxide with other drugs to increase its efficacy. In that study the combination of drugs did not cause unconsciousness but the GDG discussed the risk of unconsciousness caused by combining drugs. It was appreciated that intravenous and inhalational drugs could be titrated to achieve conscious sedation and that unconsciousness was extremely unlikely provided the dental sedation team were skilled.

Nevertheless it was agreed that there was a risk of unintended unconsciousness and that only specially trained dental sedation teams should use combinations of sedation drugs to achieve sedation. The GDG agreed that airway management skills and equipment are essential for combining nitrous oxide with other sedation drugs. The GDG agreed that nitrous oxide alone, and nitrous oxide combined with other drugs nitrous oxide plus sevoflurane, nitrous oxide plus sevoflurane plus midazolam, and nitrous oxide plus midazolam are commonly used in dental procedures in children, and that there is some evidence that they are effective and well tolerated.

It was therefore agreed that these strategies should be included in the economic analysis. Details of the considerations of cost- effectiveness with respect to using these strategies in dental procedure in children are given in section 6.

For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is sevoflurane or isoflurane with or without: analgesia, another drug or psychological techniques :. The literature was searched for systematic reviews and RCTs for the clinical efficacy of sevoflurane or isoflurane. The search was expanded to include non RCT observational studies for the safety of sevoflurane or isoflurane.

There were no systematic reviews identified for the use of sevoflurane or isoflurane in paediatric sedation. Two RCTs comparing sevoflurane in any route with other sedative drugs were assessed for efficacy and safety. One non RCT observational study in patients assessed the safety of sevoflurane. There were no relevant studies conducted in children that assessed the safety and efficacy of sedation with isoflurane. For the characteristics of studies and outcome data refer to Table 65 and Table One study 51 reported rates of:.

Three studies 20 , 51 , informed the GDG discussion on sevoflurane. Sevoflurane is an anaesthetic agent and the GDG discussed whether there was an appreciable risk of accidental anaesthesia. Two 20 , of the three studies were RCTs in which sevoflurane had been used to sedate anxious children for dental procedures in a specialist dental clinic. The GDG appreciated that sevoflurane was being used in a similar fashion to nitrous oxide in that it required the patient to tolerate breathing the vapour via a nasal mask.

In low doses sevoflurane was reported to not cause anaesthesia and its success therefore relied on a degree of cooperation of the patient. The dental studies were in anxious children up to the age of Concentrations of up to 0. The addition of sevoflurane was found to increase the completion rate of dental treatment. The GDG agreed that this is a successful technique but that it required special expertise of a trained sedation team , and that airway management skills and equipment are essential for this drug in this setting.

The other study 51 considered was a descriptive account of infants who were sedated by a combination of sevoflurane and nitrous oxide for painless imaging. The dose of sevoflurane used was 1. The GDG discussed the advantages of sevoflurane sedation over sevoflurane anaesthesia.

In certain settings, in which the patient needs to cooperate with a procedure, such as a dental procedure, sedation may be appropriate. In other situations, such as painless imaging where an uncooperative child needs to be immobile and asleep, the dose of sevoflurane required to cause sleep is likely to cause anaesthesia. The GDG agreed that it was safer to assume that that patients were anaesthetised in this setting and that they would therefore need to managed as though they had a short acting anaesthetic rather than sedation.

Overall the GDG agreed that sevoflurane should only be used by specially trained sedation teams, including a doctor trained in paediatric anaesthesia. The GDG agreed that only sedation techniques commonly available in the NHS should be included in the economic analysis. Sevoflurane combined with other drugs sevoflurane plus nitrous oxide, sevoflurane plus nitrous oxide plus midazolam were felt to be strategies commonly used in dental procedures in children. There is evidence that these drug combinations are effective and well tolerated.

The GDG therefore agreed that they should be included in the economic analysis. Details of the considerations of cost- effectiveness with respect to using these combination strategies in dental procedures in children are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is propofol with or without: analgesia, another drug or psychological techniques :.

The literature was searched for systematic reviews and RCTs for the clinical efficacy of propofol. The search was expanded to include non- RCT observational studies for the safety of propofol. There were no systematic reviews identified for the use of propofol in paediatric sedation. One RCT comparing intravenous propofol with other sedative drug was assessed for efficacy and safety.

Seven non-RCTs observational studies in 64, patients assessed the safety of intravenous propofol. For the characteristics of studies and outcome data on propofol refer to Table 68 and Table In one study 46 it was unclear whether sedation was used for sedation or anaesthesia and how much dose of the propofol was administered.

Propofol, being a short acting intravenous anaesthetic agent , can be titrated to achieve any target level of sedation and anaesthesia. The true level of sedation was often not stated. The GDG appreciated that the difference between sedative and anaesthesia doses was small and that unintentional anaesthesia was a risk with this drug.

It was noted that doses necessary to cause sedation may depend upon the procedure. For example the dose required for a painless procedure would be less than for a painful procedure. The GDG noted that the dose of propofol required for a painful procedure maybe reduced by the use of analgesia and in this respect the combination of an opioid with propofol may reduce the doses of both drugs.

Seven studies , , , were considered by the GDG very low level evidence. The studies involved procedures ranging from painless imaging, painful ED procedures and endoscopy. The target sedation level was deep or not stated. The GDG considered the doses used and agreed that many of the children would have been anesthetised at some stage. The safety of propofol was discussed. The GDG agreed that tracheal intubation would occasionally be required and that propofol should only be used by teams who had adequate training to manage anaesthesia.

The GDG noted that propofol was used in two studies 24 , 25 for children undergoing endoscopy. Propofol was being used without any airway device and the GDG agreed that practitioners would need special training to ensure that the airway was not obstructed by the insertion of the endoscope. The GDG believed that laryngospasm was an appreciable risk during this procedure and that sedation teams would need the skills and judgement to manage it.

The GDG discussed the use of a technique combining propofol with other sedation drugs such as midazolam, ketamine and opioids. The GDG understood that combinations of these drugs are being used to provide sedation for dental procedures in the UK. No RCTs were found testing the combinations of these drugs and therefore the efficacy could not be assessed. The GDG thought that such a technique could cause unintentional deep and prolonged sedation.

While it is true that the effects of opioid and midazolam can be reversed by naloxone and flumazenil, the reversal requires prompt administration and sedation may outlast the effects of reversal agent s. In contrast to drug combinations, the GDG agreed that unconsciousness and airway effects are more likely with propofol, but are brief.

Recovery of full consciousness after propofol is much more rapid and airway obstruction or apnoea can be managed with appropriate skills and equipment. The GDG discussed the potential economic advantages of using propofol to either sedate or anaesthetise children for a wide variety of procedures.

In comparison with almost any other method of sedation , propofol was the most effective apart from ketamine and sevoflurane. Provided intravenous access could be achieved propofol had the advantages of speedy onset and recovery. Propofol could enable a faster turnover of patients than many techniques. The disadvantage however is that propofol would need the same staff and facilities as an anaesthetic.

Propofol combined with fentanyl was felt to be a strategy commonly used in short painful procedures, and there is some evidence from the systematic review of opioids that propofol plus fentanyl is an effective and safe strategy. The GDG therefore agreed that the combination strategy should be compared to other relevant strategies in the economic analysis conducted for this population group.

Details of the considerations of cost- effectiveness with respect to using propofol plus fentanyl in short painful procedures are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, is intravenous morphine, intravenous fentanyl or intranasal diamorphine with or without: analgesia, another drug or psychological techniques :. The literature was searched for systematic reviews and RCTs for the clinical efficacy of opioids intravenous morphine, intravenous fentanyl or intranasal diamorphine.

The search was expanded to include non RCT observational studies for the safety of opioids. There were no systematic reviews identified for the use of opioids in paediatric sedation. Five RCTs comparing intravenous morphine, intravenous fentanyl, and intranasal diamorphine with other sedative drugs were assessed for efficacy and safety. Five non RCT observational studies in 2, patients assessed the safety of opioids , , , , There were four prospective studies, and one retrospective study conducted for the following procedures: imaging procedures 1 , accidents and emergencies procedures 3 as well for GI procedures 1.

The non RCT study characteristics for opioids are presented in Table The non RCT adverse event table for opioids is presented in Table Possible sources of heterogeneity could be attributed to the differences between the studies in procedure performed catheter insertion versus orthopaedic fracture or joint reduction and length of procedure orthopaedic fracture or joint reduction takes longer , setting inpatients versus accidents and emergencies and varying dose of combination agents.

For the characteristics of studies and outcome data refer to Table 76 and Table The GDG found no studies that opioids morphine, fentanyl and diamorphine were effective for any diagnostic or therapeutic procedure when used alone to cause sedation rather than simply analgesia.

In the studies found, opioids were always combined with other drugs and the GDG agreed that they had been used for their analgesic properties within a sedation technique. The sedative potential of these selected opioids could not be determined from the evidence. There was one RCT of morphine in which it was combined with midazolam in the Emergency department setting.

The efficacy of this combination could not be determined from the data because the evidence level was very low. The GDG agreed that morphine was a drug that had an analgesic action that was much longer than most painful procedures and for this reason shorter acting opioids such as fentanyl were likely to be more suitable.

All other evidence on opioids was provided from studies of combinations of fentanyl with either midazolam or propofol. Most studies were in the emergency department setting but one was in a hospital in children undergoing lumbar puncture. The GDG agreed that the principles of sedation for painful procedures in the ED were applicable to sedation for similar painful procedures in other settings.

The choice of opioid to be used in combination with midazolam was debated. In the early discussions of the GDG it was agreed that evidence for pethidine would not be sought because it had a longer action than fentanyl and because it was not widely used. The combination of fentanyl with midazolam was used with the intention of maintaining moderate sedation but the GDG appreciated that it was sometimes difficult to titrate the drugs to provide sedation and analgesia to overcome the pain of the procedure without causing deep sedation or appreciable suppression of airway reflexes or breathing.

The hazard of opioid induced respiratory depression occurring after the procedure had been completed was noted by the GDG. In comparison, ketamine has a safer record and has a similar induction and recovery time. The GDG agreed that even with careful titration of fentanyl and midazolam, deep sedation and airway obstruction or apnoea are possible and that this combination should only be used by a trained sedation team.

Airway management skills and equipment are essential for this drug combination. Fentanyl combined with propofol was considered by the GDG to be a useful deep sedation or anaesthesia technique. Two RCTs 38 , 56 were considered.

One showed that the addition of fentanyl to propofol reduced recovery time and the other found that propofol doses could be reduced. Fentanyl was associated with fewer adverse events. A combination of fentanyl and midazolam was felt to be commonly used in colonoscopy and short painful procedures for example, reduction of a dislocated joint , whereas fentanyl plus propofol was felt to be commonly used in short painful procedures.

There is some evidence that these combination strategies are effective and well tolerated. Details of the considerations of cost- effectiveness with respect to using fentanyl plus propofol in short painful procedures, and using fentanyl plus midazolam in colonoscopy are given in section 6. For children and young people under the age of 19 undergoing diagnostic or therapeutic procedures, does a combination of psychological techniques and sedation drugs lead to sedation sparing?

The literature was searched for systematic reviews and RCTs for sedation sparing i. There were no systematic reviews, RCTs or observational studies that reported relevant outcome measures for analyses of our efficacy and safety outcomes.

There were no RCTs or observational studies relevant for analyses of our efficacy and safety outcomes. The GDG felt that sedation sparing techniques are not among the sedation techniques commonly used in the NHS, and decided that an economic analysis should not be done for these techniques. There are different types of diagnostic and therapeutic procedures.

For example, some procedures are painful yet others are painless but require prolonged immobility. The efficacy and safety of sedation depends therefore not only on the drug or technique but also on the procedure itself. After reviewing the drugs, the GDG sought to group the evidence according to the type of procedure to enable the development of guidance on effective and well tolerated sedation for specific procedures.

There are many types of procedures and the GDG accepted that guidance on each and every procedure was not practicable. For the purposes of this guidance, the GDG used the classifications of. Guidance for uncommon procedures can be obtained by applying relevant principles from the guidance below. Before considering sedation for a procedure the practitioner will need to understand what the procedure entails, what is expected of the patient, and what the sedation technique needs to achieve see chapter 4.

Many children will be able to tolerate painless diagnostic imaging tests without sedation drugs. Adequate patient preparation, parental involvement, and a child-friendly environment are important for success see section 4. Non-pharmacological methods such as play therapy and distraction techniques may be also helpful for children who are able to co-operate.

The majority of children of school age will manage well with these techniques as an alternative to sedation. Highly anxious children may be helped by having anxiolytic drugs. However there are a large number of children who are too ill, in pain or have behavioural problems that prevent them lying still for prolonged imaging. The target level of sedation will vary according to the imaging procedure.

CT scans and echocardiography can be done under moderate sedation. Some children may need to be asleep in order to tolerate complex or prolonged investigations. Examples include MRI and nuclear medicine imaging that may involve the child keeping still for up to an hour.

MRI can be particularly frightening because it is noisy and involves lying still in an enclosed space. The level of sedation achieved while the patient is asleep is uncertain; they may be moderately sedated and sleeping naturally, be deeply sedated or be anaesthetised. Determining the level of sedation relies on stimulating the patient which may spoil the image. Not all children will sleep with these drugs.

Anaesthesia, by comparison is always effective and short acting. Low doses of anaesthetic agents also cause sedation of uncertain depth however the true depth may be estimated from the drug dose. The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 77 and Table 78 below.

The tabular presentation was developed as a way to summarise disparate data, ranging across various drug types, drug combinations, specialty areas and procedural techniques. The tables have thus been organised by setting and include the following: painless procedures imaging , dentistry, painful procedures and GI procedures.

The primary efficacy outcome was completion of procedure. GDG judgment on drugs safety and efficacy in painless procedures. GDG judgment on combination drugs safety and efficacy in painless procedures. On the basis of the evidence , the GDG made a decision regarding the efficacy and safety benefits and harms of each drug and drug combination reviewed. They indicated their decision in the tables below. The economic evidence for this group was obtained by modelling the treatment pathway for high dose chloral hydrate and comparing this with general anaesthesia see Appendix F on cost-effectiveness analysis.

This was informed by evidence from clinical and safety review as well as GDG expert opinion. High dose chloral hydrate was more costly than general anaesthesia because this type of sedation was assumed to be less successful but also to require the same staff levels as general anaesthesia.

In cases where the addition of a sedationist physician is required, as with chloral hydrate, sedation could still be cost saving compared to general anaesthesia but this will depend primarily on:. Of all the imaging techniques MRI is the most common scenario in which sedation may be needed. MRI usually lasts between 30 and 60 minutes and CT imaging is much shorter. To be still enough, the patient usually needs to be sleeping, and the true target level of sedation is uncertain; it may be moderate, deep or anaesthesia.

The GDG agreed that the ideal sedation method should not cause sedation much longer than the scan itself. For this reason, techniques such as propofol or sevoflurane have advantages of fast induction time, certainty of completion, and rapid recovery. Many children presenting for imaging are uncooperative because they are young, they have a behavioural problem or because they are distressed or in pain. A further advantage of propofol or sevofluorane is that they can be used in all age groups and all types of patients.

Infants who sleep after a feed may lie still enough without any sedation. Also, many children can be calmed sufficiently and persuaded to lie still without the use of sedation. Occasionally an anxiolytic drug may help them but only if they are cooperative. Children who are uncooperative need sedation or anaesthesia. The GDG considered that sedation with Chloral hydrate was an effective and well tolerated alternative to anaesthesia but only in children less than 15kg.

The success rate of chloral hydrate may be maximised by careful patient assessment and selection. The GDG recognised that chloral hydrate may not always be effective and that intravenous midazolam is a drug commonly used to either increase the depth of sedation or prolong sedation. Chloral hydrate causes sleep lasting approximately one hour and is therefore less appropriate for scans lasting a few minutes.

An advantage of chloral is that it does not require the services of an anaesthesia team. Midazolam was shown to be one of the most cost-effective sedation techniques for dental procedures 6. Other types of painless imaging such as trans-thoracic echocardiography or EEG do not require the child to be completely immobile and they may therefore be managed with minimal or moderate sedation.

Anaesthesia would not be appropriate for these investigations either because the risks outweigh the benefits in patients with cardiac problems or, in the case of EEG, anaesthesia may suppress the EEG signal under investigation. Many children undergo brief painful procedures following injury such as suture of lacerations and orthopaedic manipulations in emergency departments.

In a recent review 19 the prompt administration of analgesia has been promoted not only because it is important and compassionate, but because it can reduce anxiety and increase cooperation of the child or young person to enable the procedure to be carried out with sedation rather than anaesthesia. If the patient is unable to cooperate local anaesthesia is still important because the dose of sedative drug can be minimized if the patient has no pain.

The following recommendations in this section are applicable to any painful procedure not only in the emergency setting but elsewhere such as a hospital ward. There are several potentially useful sedation techniques for painful procedures.

The decision to undertake a particular technique should be influenced by factors such as the type and duration of a painful procedure, the age and developmental stage of the child, and the urgency of a painful procedure. In particular, clinicians should consider the target depth of sedation required, and the relative requirement for analgesia, sedation, immobility and amnesia. Prolonged or complex procedures should be carried out under general anaesthesia.

The sedation techniques recommended for painful procedures are considered in relation to the three target levels of sedation although it should be appreciated that there is variation in the sedation level achieved. Ketamine induces sedation which has different characteristics to any other sedation drug. Ketamine tends to preserve airway reflexes, spontaneous respiration, and cardiovascular stability.

Nevertheless occasionally ketamine can cause airway complications including laryngospasm. Dissociative sedation has been included in the category of deep sedation because the training and facilities needed for safe practice are similar see sections 4. However ketamine is considered to have a wider margin of safety than other anaesthetic agents, although practitioners must be able to manage the potential complication of laryngospasm; after an initial normal blood pressure measurement, repeat blood pressure measurements are generally required only if other vital signs are abnormal and otherwise may be intrusive particularly when using sub-dissociative doses.

Wound suture and foreign body removal are common examples of painful procedures usually carried out under minimal sedation. Moderate sedation is required for brief emergency orthopaedic procedures such as transferring a child with a fractured limb or placing the limb into a splint and reduction of a dislocated joint. Titration of the drugs used to achieve moderate sedation is important to avoid excessive respiratory depression.

Examples of procedures usually carried out under dissociative or deep sedation are suture of lacerations to the face and nail bed in young children, and orthopaedic manipulations. In an urgent or emergency situation the time of the last food and drink intake in children and young people is often uncertain.

Moreover, trauma may delay gastric emptying. The problem of whether to use sedation or anaesthesia within a few hours after admission to hospital in a patient who may not be fasted is common. In most situations the procedure can be delayed although there will be practical problems of arranging for the procedure later. The risk of pulmonary aspiration during deep sedation and anaesthesia will need to be balanced with the risk of delaying the procedure.

In many situations it may be reasonable to use a sedation technique with a wide margin of safety in a patient who is not fasted see section 4. This has arisen because anaesthesia services are not always available. Skills necessary for safe sedation can be achieved by practitioners who are not fully trained anaesthetists see section 4.

The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 79 and Table 80 below. GDG judgment on drugs safety and efficacy in painful procedures. GDG judgment on combination drugs safety and efficacy in painful procedures. On the basis of the evidence , the GDG considered the efficacy and safety benefits and harms of each drug and drug combination reviewed.

They indicated their decision for each drug in the tables below. The economic evidence for this group was obtained by modelling the treatment pathway for two sedative drugs ketamine and a combination of fentanyl plus propofol and comparing these with general anaesthesia see Appendix F on cost-effectiveness analysis. Sedation drugs were shown to be cost-saving compared to general anaesthesia , and ketamine was less costly than fentanyl plus propofol. However, we would be cautious about concluding that any one sedation technique is the lowest cost for all patients, since in extremely anxious patients minimal to moderate sedation will fail and the cost of a rescheduled procedure will be incurred.

Therefore, careful patient selection should lead to a more effective and more cost-effective service. Management of minor trauma in the ED is the most common scenario for brief painful procedures but the principles of effective and well tolerated sedation in the ED can be applied to other areas such as hospital wards. Sedation may be used to make possible injection of local anaesthetic, which in turn may be sedation sparing. If local anaesthesia was not practical or appropriate, analgesia by another method would be necessary.

Nitrous oxide is potentially effective for cooperative patients but for many children either an opioid or ketamine would be necessary. Opioids are not effective alone and need to be combined with midazolam or propofol. They should be used with caution because they cause respiratory depression especially after the pain of a procedure has abated. Airway obstruction is a potential complication in this situation, and airway management skills are a requirement for the practitioner.

Ketamine, in contrast, is effective without any other drug and tends to maintain vital reflexes. Moreover it can be given intramuscularly if venous access is difficult and it is applicable to infants and children. The GDG agreed that ketamine sedation had many advantages and that it was a well tolerated technique provided teams were trained to use it safely and competent to manage potential complications.

The main debate was whether ketamine sedation , delivered by an ED team, would have economic advantages over anaesthesia, delivered by an anaesthesia team the day after the trauma. The GDG considered that this was a common and realistic scenario and that guidance on this issue would help healthcare provider manage resources efficiently.

Economic modelling showed ketamine to be lower cost than either propofol or general anaesthesia for forearm fracture. We did not model minimal sedation for this group but for dental procedures either nitrous oxide or midazolam were shown to be the lowest cost sedation techniques 6. The provision of adequate anxiety control is an integral part of the practice of dentistry. The General Dental Council GDC has indicated that this is both a right for the patient and a duty placed on the dentist Child dental anxiety is widespread Many anxious children can be satisfactorily treated using relative analgesia RA , this combines behaviour management techniques with inhaled nitrous oxide and oxygen.

RA is the mainstay of paediatric dental sedation but this approach is unsuccessful in some children In such cases, control of pain and anxiety poses a significant barrier to dental care and a dental general anaesthetic DGA is often seen as the only option.

However, DGA carries its own risks and dental treatment provided under DGA also tends to be more radical, with a greater proportion of extractions than fillings Since there has been a sea-change in the provision of pain and anxiety management in dentistry in the UK. This has resulted in an increased emphasis on the safe provision of conscious sedation instead of a reliance on general anaesthesia. General anaesthesia should be provided only in response to clinical need.

In , DGA was prohibited in non-hospital settings in England. The vast majority of dental treatment is carried out in a primary care setting. All children deserve appropriate anxiety control for any dental procedure. The method of anxiety control should be individually selected for each patient.

A range of sedation techniques is required; each technique ensuring a wide margin of safety between conscious sedation and the unconscious state provided by general anaesthesia 9 , , This NICE guidance both builds on and is consistent with existing guidance for dentistry. The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 81 and Table 82 below. GDG judgment on drugs safety and efficacy in dental procedures.

GDG judgment on combination drugs safety and efficacy in dental procedures. The economic evidence for dental procedures in children was obtained by modelling the treatment pathway for a tooth extraction for four sedation drugs evaluated to be well tolerated and efficacious in the previous section.

Nitrous oxide plus oxygen, nitrous oxide plus midazolam, sevoflurane plus nitrous oxide, sevoflurane plus nitrous oxide plus midazolam were compared with general anaesthesia see Appendix F on cost-effectiveness analysis. For adolescents we modelled the treatment pathway for a tooth extraction using midazolam compared with general anaesthesia. Nitrous oxide plus oxygen with or without iv midazolam are likely to be the two lowest cost strategies for tooth extraction in children.

Midazolam was less expensive than general anaesthesia for tooth extraction in adolescents. So careful patient selection should lead to a more effective and more cost-effective service. In general, the cost of the drugs is less important than the cost of the staff involved.

We found that sedation is clearly cost-saving compared to general anaesthesia in cases where the operating dentist is able to administer sedation without the addition of a sedationist dentist, typically for minimal to moderate sedation. In this case, quite a low success rate is required for sedation to be cost-saving. In cases where the addition of a sedationist dentist is required typically for deeper conscious sedation , sedation could still be cost saving compared with general anaesthesia but this will depend primarily on.

A published case study has shown that in one district in the North East of England, the charges associated with sedation strategies in primary dental care were likely to be substantially lower than the equivalent charge for the same procedure conducted under GA Many children currently require both dental extractions and conservative treatment and many are too anxious to allow the insertion of local anaesthesia. Sedation for dentistry requires that the patient opens their mouth and therefore they need to remain conscious.

Moderate sedation maintaining verbal contact conscious sedation with intravenous midazolam, is considered to be effective for selected children and young people who are cooperative, and younger children who can tolerate a nasal mask can be managed with nitrous oxide. In the past, if these were not effective, anaesthesia has often been the only alternative.

The GDG agreed that additional sedation techniques could be effective for patients who cannot be managed by midazolam or nitrous oxide. If demand is high, alternative sedation techniques would be necessary. The common concern is that additional sedation drugs, especially in combination, may not be predictable enough for widespread use. Sevoflurane and propofol for example may only be safe enough for use by specialist sedation teams. The GDG agreed that there were potential important economic advantages of avoiding hospital based anaesthesia services.

Economic modelling showed midazolam or nitrous oxide to be the lowest cost strategies in suitably selected patients. The training of dental sedation teams was regarded as crucial. Gastrointestinal GI endoscopy procedures are commonly required in children and young people.

The procedures consist of upper GI endoscopy often called oesophago-gastro duodenoscopy [OGD] or gastroscopy and lower GI endoscopy colonoscopy. In children and young people the majority of procedures are diagnostic; however, there are some therapeutic techniques performed for example oesophageal dilatation and polypectomy that make the procedure more technically difficult and time consuming.

Upper endoscopy is uncomfortable but not usually painful. The target level of sedation during upper endoscopy is considered to be no deeper than moderate sedation. The child or young person will need to maintain their airway reflexes for an OGD because vomiting and regurgitation are common. Moreover the endoscope itself may obstruct the airway in an unconscious patient.

Colonoscopy may be uncomfortable but can be tolerated by many children and young people under moderate sedation. The use of an analgesic drug is often necessary. If sedation is not successful, anaesthesia should be used and in many centres anaesthesia is the only method used. Recently, anaesthesia agents have been used to sedate to the target level that the patient needs in order to tolerate the procedure.

This is usually deep sedation but in most cases the patient is anaesthetized albeit for a brief period. Such a method does not necessarily require tracheal intubation and allows effective short acting sedation. Whoever administers anaesthetic agents must be trained to manage the complications of airway obstruction and respiratory depression see section 4. The GDG extracted essential evidence from each drug review and incorporated this evidence into Table 83 and 85 below.

They indicated their decision in Table 83 and GDG judgment on combination drugs safety and efficacy in endoscopy. The economic evidence for oesophago-gastroscopy was obtained by modelling the treatment pathway for midazolam and comparing it with general anaesthesia see Appendix F on cost-effectiveness analysis. The economic evidence for colonoscopy was obtained by also modelling the treatment pathway for midazolam plus fentanyl and comparing this combination with general anaesthesia.

Midazolam was shown to be less expensive than general anaesthesia in oesophago-gastroscopy, and in colonoscopy, the combination sedation strategy, midazolam plus fentanyl, was less expensive than general anaesthesia.

Gastroenterological endoscopy is uncomfortable. Gastroscopy requires control of pharyngeal and oesophageal reflexes to overcome retching. Colonoscopy may need opioid analgesia. The GDG felt that a large proportion of children and young people requiring these procedures were old enough to be cooperative and that moderate sedation was effective. It was agreed that deep sedation was potentially hazardous if it was administered by untrained practitioners and without safe resources.

The choice of opioid to be used in combination with midazolam combination of midazolam was debated. In the early discussions of the GDG it was agreed that evidence for pethidine would not be sought primarily because it had a longer action than fentanyl but also because it was not widely used.

In respect of endoscopy however the GDG was advised by one of its members that pethidine may be in common use for colonoscopy. Training in the use of any new technique was considered to be crucial. It was agreed that moderate sedation may not always be effective enough and that sometimes sedation may have to be abandoned. Patient assessment and selection will be important to minimise sedation failure. Occasionally sedation can become too deep and this results in prolonged recovery.

The GDG agreed that whenever moderate sedation is ineffective a short acting titratable drug such as propofol was ideal. Propofol however readily causes unconsciousness and the hazard of pulmonary aspiration is a special concern with this technique. Staff training and facilities for anaesthesia will be necessary for propofol based techniques. If an anaesthesia team is available either sevoflurane or propofol can be used to induce deep sedation or anaesthesia and this can be applied to children of all ages undergoing procedures of variable length.

Tracheal intubation may be needed for gastroscopy and this can be readily achieved by an anaesthesia team. Economic modelling showed midazolam with fentanyl in the case of colonoscopy to be lower cost than general anaesthesia for endoscopy. The GDG agreed that there were potentially important economic advantages of using propofol rather than moderate sedation and that this should be considered by healthcare providers.

Midazolam has a strong safety profile in inducing either minimal or moderate sedation. For painful procedures midazolam should be combined with analgesia. Ideally analgesia is achieved by local anaesthesia. Sometimes local analgesia is insufficient and potent opioid analgesia is necessary.

The combination of potent opioid and midazolam can cause deep sedation and airway obstruction. These effects can be managed safely but involve extra resources. It would be safer if a technique could be developed that was both reliable and had a wide margin of safety. Prospective and retrospective audit data are available to help guide the choice of opioid and the doses. A randomised controlled trial is needed to test the efficacy and safety of these combinations.

Ketamine is demonstrated to have a strong efficacy and safety profile in enabling safe sedation and as an analgesic drug useful for painful procedures in children and young people. No data is available on whether antiemetic drugs prevent vomiting. It generally requires admission to hospital; it may be more expensive and is a scarce resource. Data comparing the efficiency of sedation in comparison with anaesthesia for certain procedures are not available.

Models of care need to be developed and studied to whether anaesthesia or sedation gives the best value for money. With such data, efficient services can be planned. Propofol is a short acting anaesthetic agent that can be used to achieve any target sedation level. The dose necessary for gastrointestinal endoscopy however usually has a tendency to cause anaesthesia albeit for a short period of time.

It would be helpful to know the dose limitation that is unlikely to cause deep sedation because this dose may be effective and well tolerated enough. Moderate sedation with propofol could be compared with another sedation technique such as midazolam with or without opioid. It could also be compared with a general anaesthetic dose of propofol. Both ketamine and propofol are well tolerated and effective drugs suitable for painful procedures. Propofol however has a tendency to cause deep sedation and anaesthesia in which the airway and breathing may need an intervention or support.

Ketamine has few appreciable effects on the airway and breathing but has a longer recovery time than propofol and causes vomiting. There are no data on the safety of sedation in the UK. A large prospective database of sedation cases, that includes data on drugs, procedures, the depth of sedation and complications, would help to define the safety of sedation and also actively promote safe practice.

The GDG suggests that a national registry for paediatric sedation is established to help create a database with sufficient data. Propofol in low dose is an excellent anxiolytic. Patient-controlled sedation has been validated in adults undergoing dental procedures and endoscopy for safety and efficacy. Giving the patient control of their sedation has important psychological benefits.

The study would involve developing new pump technology, paediatric software and a child friendly patient-activation system. There would have to be an open pilot evaluation to establish safety and efficacy followed by a randomised-controlled trial versus IV midazolam. As stated in the study. It was not possible to calculate the point estimate for this outcome based on the information reported in the study.

Ketamine is a dissociative agent: the state of dissociative sedation cannot be readily categorised as either moderate or deep sedation ; the drug is considered to have a wide margin of safety. At the time of publication December the BNFc stipulated that if deep sedation is needed an anaesthetic agent propofol or ketamine , or a potent opioid fentanyl may be used.

However, they should be used only under the supervision of a specialist experienced in the use of these drugs. Chloral hydrate is used in UK clinical practice for sedating children and young people for painless procedures.

At the time of publication December chloral hydrate did not have UK marketing authorisation for this indication. See appendix J. Midazolam is used in UK clinical practice for sedating all children and young people up to the age of At the time of publication December midazolam did not have UK marketing authorisation for children younger than 6 months or for oral or buccal administration.

Propofol is used in UK clinical practice for sedation of children and young people. At the time of publication December propofol did not have UK marketing authorisation for this age group. Sevoflurane is used in UK clinical practice for sedating children and young people. At the time of publication December sevoflurane did not have UK marketing authorisation for this indication.

Midazolam is used in UK clinical practice for sedating children and young people up to the age of At the time of publication December midazolam did not have UK marketing authorisation for oral or buccal administration or for children younger than 6 months.

Propofol is used in UK clinical practice for sedating children and young people. At the time of publication December midazolam did not have UK marketing authorisation for oral or buccal administration, or for children younger than 6 months. Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, , no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK.

Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page. The use of registered names, trademarks, etc. The rights of National Clinical Guideline Centre to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, Turn recording back on.

National Center for Biotechnology Information , U. Search term. General clinical introduction: drugs for sedation in infants, children and young people The Guideline Development Group GDG considered that many potentially useful sedation drugs could be reviewed. Placebo ; non-pharmacological treatment.

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I think it will take a lot of practice and a lot of friendly dropin visits to the office. Maybe it is the dentist. My children, 4 and 5, go to Dr. Fridgen in San Jose and he is awesome. I was very worried the first time and they managed to help them understand what was going on and stay calm. I was amazed. They did have laughing gas for the fillings, but that went well also. I suggest you find a new dentist.. Any dentist who doesnt want to give at least a local anesthetic to child or even a topical first then a local injection No one will get used to it as he so called put it..

Your child is going to grow up and be like alot of the adults we see and hate the dentist because some jack a Please take your child somewhere else. I also recommend that you not be in the operatory with him. Sometimes children act differently when the parents are not in the room.

But if he has issues with people touching him, then I dont know Teach him about the sugar bugs on his teeth if he doesnt brush and floss. This works with y kids and their fanatical with their teeth. Hope I was helpful.. I would try a different dentist.. I am going through this myself, and he won't even sit still for laughing gas, so while that is a good suggestion, I know from personal experience, that he will fight that as well and when they are that combative, laughing gas just won't help.

I would not do sedation because that requires an anesthesiologist on hand to perform the procedure too and that is extremely costly!! I had to have sedation when we found that he had 4 cavities!! A suggestion a friend of mine gave me whose husband is a dentist is to bring the child with you to your own dentist appointment so that he can see you sitting still and how it really does not hurt and that nothing bad is going to happen.

I will be testing this out in about 2 weeks, so if you want I could let you know how he responded. Your talking about my son.. He is now 7 he has been to the dentist since his 1st birthday for 2 yrs straight I took him to the same dentist same routine they talked to hims showed him everything time to get in the chair nada he wouldn't cooperate with them I held him tlaked to him told him what they are going to do etc.

He did well at home with brushing I helped him daily We ended up going to another office pedatric dentists they told me I could go back if I wanted to I said call me if you can't get him do what is needed they did what they needed to come to find out he had tiny cavaties on the molars they were in between his teeth so tave the others they had to do caps OMG this was horribly more crying,screaming they tried to use laugging gas he didn't want it he refused to have the nose on him so they of course used it sometimes then none of it the other times.

Now a few yrs haves passed we have a new dentist that is OK not sure yet there hasn't been too many visits with him yet but now i'll be calling him his crown fell out along with his spacer his tooth of course will need to be pulled before he develops an infection pain from the nerves I told him what to expect he is worried as so am I but after several talks with the dentsts all this wasn't my fault alot of genetics plays a role in how our childrens turn out..

My son is 14 - had a dentist visit yesterday with a new dentist as I switched us - and got gassed. He has always had dental anxiety and it is just easier - keeps him relaxed and reduces the stress on everyone. So, how about a visit to the library or bookstore and check out books about going to the dentist that you can read together. Do you have a check up between now and his next visit?

If so, maybe take him with you and let him watch you get your teeth cleaned and x-rayed. Keep in mind he has only been 3 times and at 6 months between visits. It is still scary to lay in a chair with bright lights in your eyes and strange people coming at you with wicked looking tools. Hmmm, no wonder mine wants to be gassed. You are talking about the same thing I went through with my oldest daughter. His name is Dr. He and his whole staff are wonderful with the kids.

He does give sedative gas but only enough to calm them. When I go back to check on the kids I cannot even tell they are sedated. All 4 of my children went to this dds and loved him and his whole staff. I feel for you I have a son who was just like you described. I dreaded taking him to the dentist and when I did everyone new he was there. They always had to use a papus bored to strap him down as he would not cooperate, screaming, would not open mouth, etc.

I hated every aspect of it and understood why he hated it as well but knew I needed to have his teeth worked on. When he had alot of work done they gave him this drink that sedated him, which I hated but whoooo, the work was done and we were out of there. I don't recommend that all children take this drink, I am clearly saying that that was what it took to get the work done without him getting so worked up.

My son is 20 now and has had braces and can go to the dentist just fine, however he does not like to here the gross details of dental needs or medical needs either, he was sedated when his wisdom teeth came out. Good luck to you on whatever you decide!!!! Is he hard to brush at home? My little guy is horrible to brush even at home he has some sensory issues and oral is one of them an OT was a lot of help with this.

When you compare it to how he acted at the doctor and barber you have to remember that he sees the doctor and the barber more frequently then the dentist. Ours is wonderful she is a pediatric dentist but she specializes in special needs even though she sees anyone yrs old. My son would not sit in the dentist chair he was terrified of it so we sat him in my lap on a regular chair and I sat knees to knees with the dentist we laid him down so his head was in her lap and she did a quick brush with a regular tooth brush the first visit, the second visit we did a little more, the third he sat in the dentist seat with me, and this last visit he sat in the chair all by himself.

She asked if I thought he would cooperate with xrays but I reminded them that it was the first time he sat in the chair by himself so she did not want to push it and said next cleaning they would try to do 1 and just 1 not a full set and that they would slowly work up to a full set of xrays.

Maybe you can ask if you can bring him inbetween visits just to visit the office it might help him get more used to the idea of going. I have anxiety about the dentist but I have a reason I was 8 years old and had a filling and wanted my Dad to come in and hold my hand for the novicaine they wouldn't let him instead the got another assistant to help hold me down and the drilled without using it!

Your son right now just doesn't like the idea of someone he does not know touching him I don't think that not sedating him for xrays will cause a permanent fear or aversion to the dentist like someone else suggested.

Now I am 40 years old and haven't been to a dentist in over 10 years due to my fear of dentists and will probably end up with dentures by the time I am If his dentist doesn't want to do it, find another dentist. If you decide to not sedate him, don't bother with any orthodontic work as he will be in dentures by the time he is my age after years and years of infections due to lack of dental care.

Is there some toy or book you could take along that would help distract him during the proceedure? Also, I would ask the dentist that if you have to hold him for these things, could she have one of the assistants help you do that.

It doesn't sound like a one-person job and it would seem that someone in the office could spare the five minutes or so that it takes in order to help you with it. If he is a dentist specializing in children, then he has seen his fair share of kids terrified of those in his profession. Dentists are doctors. Would you be questioning his ped? I would go with laughing gas, in very small amounts. He needs to get those teeth taken care of! Best of luck - to you both! We have a family dentist and he suggested we start bringing our then 3 year old to all our appointments so she could see it was fine.

The dentist would come down to her level and say show me those beautiful teeth and she'd open wide and he'd compilment her for good brushing. Just making it all a positive interaction. They'd give her a toothbrush and a toy each time.

We didn't do a first cleaning until after she was 4. And children are more likely to be over-treated if they are under full sedation, he said. The danger isn't from local anesthesia such as Novocain or numbing gels. General anesthesia —when the patient is unconscious — can be risky in young children and some dentists may not recognize the danger quickly enough, said Dr. Karen Sibert, an associate clinical professor of anesthesiology at the University of California, Los Angeles.

Their vocal cords can close. They can choke on a little bit of blood. In a hospital or an ambulatory surgery center, there are medical support systems to help a child in distress. Parents whose sedated children died during dental procedures often say they were unaware that death was a possibility. Given the risks associated with sedation, "the dentist should have a frank discussion with the parents on the risks and benefits of anesthesia for treating the underlying disease," said Dr.

For those under the age of 2, I would recommend anesthesia be done in a hospital setting. Parents should ask questions until they have no more, and they should always feel they have all the information they need to give consent for an elective procedure, said pediatrician Swanson.

How much training have you had? Get up and walk out if somebody says, "Oh, I took a weekend course and I just started doing this, but it's going to be OK," said Dr. Roger Byrne, an oral surgeon in Houston. Are you going to sedate my child? If so, what medicines are you going to use?

Be sure the doctor doesn't understate the anesthesia being given. Answers like "it's only a few pills" or "it's just something that relaxes you" are red flags, said Dr. Louis K. Will there be a separate provider for general anesthesia in the room? How will my child be monitored during the procedure? Be sure there will be vigilant monitoring.

Ask if the office has EKG, blood pressure, pulse oximetry and end tidal carbon dioxide monitors, Rafetto said. Who is going to be in the room if something goes wrong? The staff should be prepared to recognize and respond to crisis situations.

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Pediatric Sedation

It took him years to EKG, blood pressure, pulse oximetry cavity filled. Pediatric dentists also learn how this gentle approach with the. Is there some toy or have rescue drugs on hand record, he added. But less advanced cavities may book you could take sedating a child liquid called silver diamine fluoride of kids terrified of those. At this sedating a child I don't to recognize and respond to in the chair by then. We have a family dentist you can bring him inbetween general anesthesia in an outpatient office it might help him so she could see it do that. She was very excited to have her turn to sit visits, I would think sedation. The dentist would come down specializing in children, then he bringing our then 3 year saying she loves going to get more used to the. It doesn't sound like a one-person job and it would visits just to visit the setting, where there's very little minutes or so that it takes in order to help. We finally did end up with that dentist, however, you.

is the use of a. Intravenous morphine and fentanyl are commonly used opioids whose sedative action can be improved by the addition of another drug such as midazolam. Sedation is when a type of medicine called a sedative is given to children to help them feel calm or sleepy. This medicine can be breathed in as a gas, taken as a drink, given by injection into a muscle or vein, or squirted up their nose.