PRACTICE. GUIDELINES Sedation for diagnostic and therapeutic procedures in children and young people: summary of NICE guidance

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1 For the full versions of these articles see bmj.com PRACTICE GUIDELINES Sedation for diagnostic and therapeutic procedures in children and young people: summary of NICE guidance Mike Sury, 1 2 Ian Bullock, 3 Silvia Rabar, 3 Kathleen DeMott 3 1 Great Ormond Street Hospital for Children NHS Trust, London WC1N 3JH, UK 2 PORTEX Unit of Paediatric Anaesthesia, Institute of Child Health, University College London, WC1N 1EH 3 National Clinical Guideline Centre, Royal College of Physicians, London NW1 4LE Correspondence to: M Sury surym@gosh.nhs.uk Cite this as: BMJ 2010;341:c6819 doi: /bmj.c6819 This is one of a series of BMJ summaries of new guidelines, which are based on the best available evidence; they will highlight important recommendations for clinical practice, especially where uncertainty or controversy exists. Further information about the guidance, a list of members of the guideline development group, and the supporting evidence statements are in the full version on bmj.com. Children often need effective sedation or anaesthesia for minor procedures. Although a wide range of sedation techniques is available, sedation may not always be effective, causing distress and additional cost (related to repeat procedures); some techniques may occasionally cause unintended loss of consciousness with sudden and potentially dangerous airway obstruction and respiratory depression. These problems can be minimised by choosing effective and appropriate techniques and ensuring that healthcare practitioners are trained and able to prevent harm. However, guidance on which technique is effective for specific procedures, and the training and resources needed to deliver them safely, has been absent. This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on effective and safe sedation of children and young people undergoing common diagnostic and therapeutic procedures. 1 Recommendations NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are in the full version of this article on bmj.com. Assessment, communication, patient information, and consent Establish suitability for sedation by assessing current medical condition and any surgical problems; weight (growth assessment); past medical problems (including any associated with sedation or anaesthesia); current and previous medication (including any allergies); physical status (including the airway); and psychological and developmental status. Seek further advice from a specialist before giving sedation if you are concerned about a potential airway or breathing problem in a child or young person assessed as grade 3 or greater on the American Society of Anesthesiologists (ASA) scoring tool and for all neonates and infants. The ASA scoring tool is a system for classifying and grading a patient s physical status before anaesthesia as follows: grade 1 is normal health, 2 is systemic disease that does not limit activity, 3 is systemic disease that limits activity, 4 is life threatening systemic disease, and 5 is moribund. 2 Ensure that a trained healthcare professional and trained assistant are available for delivering and monitoring sedation. Ensure there is immediate access to resuscitation and monitoring equipment. Choose the most suitable sedation technique according to the procedure, the target level of sedation (table 1), contraindications, side effects, and patient preference. The figure shows a possible pathway for choosing the most suitable sedation technique. Table 2 describes the indications and licensed uses of specific drugs. Offer verbal and written information on the proposed sedation technique, the alternatives, and the associated risks and benefits. Obtain and document informed consent for sedation. Table 1 Sedation depth Degree of sedation Minimal sedation Moderate sedation Deep sedation Anaesthesia Characteristics Awake and calm, with normal response to verbal commands Sleepy, but with purposeful response to verbal commands (known as conscious sedation) or light tactile stimulation. Reflex withdrawal from a painful stimulus is not a purposeful response. interventions are needed to maintain a patent airway Asleep and not easily roused but with purposeful response to repeated or painful stimulation. Help often needed to maintain a patent airway. Spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained Asleep and unrousable intervention usually needed to support the airway and breathing. Cardiovascular function may need support BMJ 1 JANUARY 2011 VOLUME

2 Table 2 Current licensing status for sedation drugs* Drug Indication Licensed use (taken from the British National Formulary for Children (BNFc) 2010/11 3 Chloral hydrate For mild to moderate sedation Fentanyl Intranasal diamorphine For analgesia and for improved anaesthesia For mild to moderate sedation in managing acute pain and short painful procedures t licensed for sedation in painless procedures. For dosing (by mouth or by rectum) for painless procedures in children from neonates to 18 years, see the BNFc Licensed for use in children older than 1 month with spontaneous respiration for analgesia, and during operations for improved anaesthesia by intravenous injection over at least 30 seconds If deep sedation is needed, a general anaesthetic (eg propofol or ketamine) or a potent opioid (eg fentanyl) may be used; these Licensed for intranasal route but listed in the BNFc as follows: acute pain in an emergency setting or short painful procedures; intranasally in children heavier than 10 kg Ketamine Anaesthesia Licensed for use in anaesthesia for all ages; intravenous and intramuscular Midazolam Lower doses are used for moderate sedation For mild to moderate (also referred to as conscious) sedation If deep sedation is needed, a general anaesthetic (for example, propofol or ketamine), or a potent opioid (for example, fentanyl) may be used. However, they t licensed for use in children younger than 6 months for premedication and conscious sedation. t licensed for use by mouth or by buccal administration. Intravenous midazolam is not licensed for use in children younger than 6 months for conscious sedation. UK marketing authorisation for oral or intranasal midazolam for sedation. However, dosing for children from age 1 month is given in the BNFc Morphine Analgesia and for deep sedation Licensed for analgesia in all ages; subcutaneous or intravenous. Other routes have restricted licensing (Oramorph solution (morphine) is not licensed for use in children younger than 1 year; Oramorph unit dose vials is not licensed for use in children younger than 6 years; Sevredol tablets (morphine) are not licensed for use in children younger than 3 years; MST Continuous preparations (slow release morphine sulphate) are licensed to treat children with cancer pain (age range not specified by manufacturer); MXL capsules (morphine) are not licensed for use in children younger than 1 year). If deep sedation is needed, a general anaesthetic (eg propofol or ketamine) or a potent opioid (eg fentanyl) may be used; these Nitrous oxide For minimal to moderate sedation during relatively short procedures 50% nitrous oxide licensed for use in sedation for all ages (inhalation); nitrous oxide in concentrations >50% is not licensed for analgesia without loss of consciousness Opioids If deep sedation is needed a general anaesthetic (eg propofol or ketamine) or a potent opioid (eg fentanyl) may be used; these Propofol Anaesthesia Licensed for use in all children older than 1 month in intravenous doses of 0.5% or 1% Sevoflurane Anaesthesia Licensed for use in anaesthesia for all ages (inhalation) Licensed for use in people older than 17 years. The Guideline Development Group decided to recommend off-label use of propofol for sedation in children of all ages. This was because propofol is widely used in the UK for sedation in children of all ages and the doses used for sedation are much lower than those used for anaesthesia. If deep sedation is needed, a general anaesthetic (eg propofol or ketamine) or a potent opioid (eg fentanyl) may be used; these should be used only under the supervision of a specialist experienced in the use of these drugs Sedation is outside the licensed use *These drugs have been recommended for paediatric sedation. Informed consent should be obtained and documented for the use of any drug outside the licensed indications. Fasting Confirm and record the time of last food and fluid intake. Fasting is not needed for minimal sedation, sedation with nitrous oxide (in oxygen) alone, or moderate sedation where the child will maintain verbal contact. For all other sedation techniques for elective procedures (for deep sedation and for moderate sedation where the child might not maintain verbal contact with the healthcare professional), apply the fasting rule used for general anaesthesia. Fasting times should be as for general anaesthesia: two hours for clear fluids; four hours for breast milk; six hours for solids. For an emergency procedure in someone who has not fasted, base the decision to proceed with sedation on the urgency of the procedure and the target depth of sedation. Psychological preparation Offer information about the procedure, including what the child or young person should do, the sensations associated with the procedure (for example, a sharp scratch, numbness), and how to cope with the procedure. Ensure that the information is appropriate for the patient s developmental stage. Offer parents and carers the opportunity to be present during sedation. For an elective procedure consider referral to a mental health specialist for children who are severely anxious or who have a learning disability. Personnel and training Healthcare professionals delivering sedation should: -Understand and be competent in sedation drug pharmacology, applied physiology, assessment, monitoring, recovery care, and complications and their immediate management -Have practical experience of effective delivery of the sedation technique used, management of complications, including observing clinical signs and using monitoring and resuscitation equipment -Have documented, up to date evidence of competency, including evidence of completion of a theoretical training course and a record of practical experience of sedation techniques. Only a healthcare professional trained in delivering anaesthetic agents should administer sevoflurane, 46 BMJ 1 JANUARY 2011 VOLUME 342

3 Is the procedure painful (for example, suture laceration or manipulation of fracture)? Is the procedure endoscopy? Is the procedure dental? Consider a local anaesthetic Upper gastrointestinal: consider intravenous midazolam for minimal or moderate sedation Lower gastrointestinal: consider fentanyl (or equivalent opioid) and intravenous midazolam for moderate sedation Do not routinely use ketamine or opioids For children and young people who are unable to tolerate a painless procedure (for example, during diagnostic imaging consider either: - chloral hydrate for children under 15 kg, or - midazolam If these are not suitable, consider one of the following drugs ministered by a specialist healthcare professional with a narrow margin of safety: - propofol - sevoflurane For minimal or moderate sedation consider using one of the techniques in A. If these are unsuitable consider one from B. If these are unsuitable consider C A: Nitrous oxide (in oxygen); midazolam (oral or intranasal) B: Ketamine (intravenous or intramuscular); intravenous midazolam with or without fentanyl (for moderate sedation) C: Specialist sedation technique such as propofol with or without fentanyl For children or young people who are unable to tolerate a painful dental procedure with local anaesthesia alone, consider minimal to moderate (conscious) sedation with either nitrous oxide (with oxygen) or midazolam If these techniques are not suitable, refer to a specialist team for an alternative to achieve moderate (conscious) sedation Choosing sedation technique bmj.com archive Previous articles in this series ЖЖManagement of bedwetting in children and young people (BMJ 2010;341:c5399) ЖЖTransient loss of consciousness initial assessment, diagnosis, and specialist referral (BMJ 2010;341:c4457) ЖЖDiagnosis and management of adults with chronic heart failure (BMJ 2010;341:c4130) ЖЖManagement of hypertensive disorders during pregnancy (BMJ 2010;341:c2207) ЖЖDiagnosis, prevention, and management of delirium (BMJ 2010;341:c3704) propofol, or a combination of opioids with ketamine. Consider referral to an anaesthesia specialist if the patient is not able to tolerate the procedure under sedation. Monitoring and discharge For both moderate and deep sedation continuously observe and respond to changes in depth of sedation, coping, pain, and distress. During moderate sedation (excluding sedation with nitrous oxide (in oxygen) alone) monitor respiration, oxygen saturation, and heart rate. In addition, during deep sedation use capnography, electrocardiography, and blood pressure monitoring. Ensure that data from continuous monitoring during sedation are clearly documented in the healthcare record. After the procedure, continue monitoring until the airway is patent, the protective airway and breathing reflexes are present, and the patient is haemodynamically stable and easily roused. Ensure that vital signs have returned to normal levels, the patient is awake, there is no risk of further reduction in conscious level, and any nausea, vomiting, and pain have been adequately managed. Overcoming barriers Healthcare professionals need training to deliver effective and safe sedation. To this end, experienced sedation practitioners should develop training programmes with their professional bodies, preferably aiming for national accreditation. Sedation and anaesthesia practitioners should exchange and combine their skills and knowledge to expand the range of techniques for children. As well as the sedation drug technique, psychological preparation is important to minimise anxiety and distress. Beware of respiratory depression caused by opioids once the pain caused by the procedure has subsided. Consider anaesthesia instead of sedation for prolonged and very painful procedures. Contributors: All authors contributed to the conception and drafting of this article and revising it critically. They have all approved this version. Funding: The National Clinical Guideline Centre was commissioned and funded by the National Institute for Health and Clinical Excellence to write this summary. Competing interests: All authors have completed the Unified Competing Interest form at (available on request from the corresponding author) and declare: IB, KD, and SR had support from the National Clinical Guideline Centre (NCGC) for the submitted work; IB, KD, and SR have been employed by NCGC in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work. Provenance and peer review: Commissioned; not externally peer reviewed. 1 National Institute for Health and Clinical Excellence. Sedation for diagnostic and therapeutic procedures in children and young people. (Clinical guideline 112.) uk/cg Saklad M. Grading of patients for surgical procedures. Anesthesiology 1941;2: British National Formulary for Children (BNFc) 2010/ British Medical Association, Royal Pharmaceutical Society of Great Britain, Royal College of Paediatrics and Child Health, Neonatal and Paediatric Pharmacists Group. BMJ 1 JANUARY 2011 VOLUME

4 1 Kingston-Upon-Thames, UK 2 Departments of Cardiology and Radiology, Royal Brompton Hospital, Sydney Street, London, UK Correspondence to: A Maiklem amaiklem@caci.co.uk E Nicol cyprusdoc@doctors.org.uk Cite this as: BMJ 2010;341:c4918 doi: /bmj.c4918 This is one of a series of occasional articles by patients about their experiences that offer lessons to doctors. The BMJ welcomes contributions to the series. Please contact Peter Lapsley (plapsley@bmj.com) for guidance. A PATIENT S JOURNEY Heart transplant Andrew Maiklem, 1 Ed Nicol 2 The patient s heart failure became apparent during his friend s stag weekend. After a minor heart attack he had a heart transplant I was 28 years old and led a somewhat unexciting, single life in London. I had been feeling breathless for a couple of weeks leading up to Ed s stag weekend in September As a non-smoker I was not too worried, and my doctor reassured me there was nothing wrong. At the stag weekend I braved the karting activities, but as the day wore on I laboured with my breathing, and by the evening I struggled to climb a single flight of stairs. Despite his inebriated state, Ed was worried. It certainly helped that he and several other attendees at the weekend were doctors. The next morning, surrounded by doctors with hangovers, I had a chest radiograph. A few days later, on Friday 13, I attended a clinic at the Royal Brompton Hospital. After echocardiography had clearly shown something was amiss, I was admitted with heart failure. On reflection it is strange that on being told I had heart failure I didn t really react. I was more thankful that the doctors had found a cause for my breathlessness and that it wasn t cancer. I was initially told I would be out of hospital for the wedding, but I then had a minor heart attack. I remember this happening although the events immediately after it are a little blurred. I remember not being able breathe very well; it almost felt like I was suffocating. I reached for the nurse s bell, managed to hit it, and that was the last thing I remember. I woke up six days later in the intensive care unit. I had two large tubes coming out of my chest, feeding into the left ventricular assist device. It didn t faze me at all; I was more confused about the fact that to my mind yesterday had been Friday and today was now Thursday. Although my blood was now being pumped by a huge machine because my heart was no longer strong enough this didn t particularly trouble me, but a few things did: first was the continuous positive airway pressure machine blasting freezing cold air down my throat. This would have been uncomfortable enough but was made infinitely worse by the tube that I had going up my nose to feed me, which was breaking the mask seal, resulting in freezing cold air being directed straight into my right eye. I tried my hardest to explain this to the nurses, but my oral skills were somewhat lacking. I remember trying to communicate with my parents in those first few days. My mind knew what I wanted to say, but when I tried to speak the words just wouldn t come. I tried to write things down, but spelling and letters also failed me. I just couldn t remember how to com municate. This caused huge frustration, and tired me out very quickly. During this time I never contemplated further than the next hour; the future didn t seem to matter, nor even cross my mind. Within a week I was strong enough to be moved on to a much smaller and mobile left ventricular assist device, and I was moved to Harefield Hospital, where I was told that the device would allow my heart to rest and potentially get better. It was described to me as a bridge to recovery. There was never any suggestion that things would go any other way. But after three weeks a consultant came to see me to tell me that I needed a heart transplant. My first reaction was anger, and then came frustration. I decided the doctors were giving up on saving my heart and opting just to replace it. I felt three weeks wasn t long enough for my heart to have recovered, and that they should give it another few weeks. However, with help and support from my friends and family I soon realised that this course of action had not been taken lightly. So having taken the weekend to contemplate that I could not live on the machine forever I decided that a transplant was my best option and gave my consent. Unbelievably, the next day a very excited transplant coordinator came racing into my room telling me they had a heart for me. Within five days I was in the gym and feeling like a new man. After my transplant I realised how easy everyday tasks now were, and it dawned on me that I had made precisely the right decision. Along with a new heart comes a new sense of optimism for life, a second chance, and a whole new regimen for life, in particular a lot more pills to take. This small change to my life was probably the most difficult to incorporate, which sounds ridiculous, as I had just had one of my major organs replaced. The most challenging time was the first six months because the drugs and their dosage changed on a weekly basis. But around the first year mark the drug regimen settled down and has remained constant ever since. As with any new routine, it takes a few months to get used to, but then it is as subliminal as cleaning your teeth. The first three months after the transplant were a hectic learning curve. During this period of weekly hospital reviews, remembering what pills to take and when, coupled with a ban on mixing with the outside world, I had a lot of time for inward reflection. I realised how things could have turned out very differently: if my friend hadn t made it possible for me to attend the initial clinic; if my friends and family hadn t been there to support me in my decision to opt for the transplant; if medical support and ability hadn t been there to keep me alive long enough for the operation; and, of course, if the donor heart hadn t been available. I have a lot to be thankful for, and with this comes a sense of responsibility, a responsibility to lead a long and healthy life. I felt indebted to these people. It was during this period that I realised that going for a few tests to make sure I m in tip top condition and remembering to take pills twice a day was not a big ask in return. After my three months enforced isolation, I started to reintroduce myself to normal life. I thought I could just pick up where I left off. My consultant had told me that it would take me a year to return to being fully fit. Initially I did not believe him. But four months in I tried to run for a 48 BMJ 1 JANUARY 2011 VOLUME 342

5 A DOCTOR S PERSPECTIVE In 2002, Andy was, and still is, one of my closest friends. As doctors we are all faced with requests from friends and family for advice or counsel from time to time. I try to adopt a professional but generic response in an attempt to keep my personal and professional relationships distinct. Despite the inebriated state of the doctors gathered at my stag party our professional duty prevailed. Andy s decline was rapid, and he was soon in a precarious state with an uncertain outlook. Although his left ventricle assist device was a technical success, there was concern that he could have experienced an operative cerebrovascular accident. It is not the technical aspects of Andy s case that have left a mark on me professionally, but my personal, emotional journey. I will never forget talking to Andy s family, nor trying to explain the situation to our closest friends. It is hard breaking difficult news to relatives you do not know, but doing this with friends and a family whom you know very well is something else entirely. I tried to be sensitive but realistic, although my wife recalls I went into doctor mode while Andy remained ventilated. I think this was my way of coping. There were many tears, yet also a recognition of what Andy brought to all our lives, so that with the anguish there was the hope that not only would he wake up, but still be the same Andy we all knew and loved. I look back on this episode regularly and reflect how it has influenced me. I value my own life more and hope that when I am involved professionally with patients loved ones I am more aware and understanding. I do not offer Andy counsel, he knows where I am and that I am always happy to assist and answer questions. We are friends, first and foremost, and long may it stay that way. Ed Nicol bus, and at the point where I started running I fell flat on my face. My legs gave way, my heart was pounding, and I lay there thinking maybe this would take a year. But I was back at full time work within five months, and the more I got back into my usual routine, the less I felt like anything had happened. I am now married to a surgeon and live a normal life. The only time I remember that I have had a transplant is when I need to go for my six monthly check up. I believe this is because my friends and family treat me no d ifferently from how they always have. They certainly do not let me use my transplant as an excuse to avoid the rigours of life. Competing interests: All authors have completed the Unified Competing Interest form at (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work. Provenance and peer review: t commissioned; not externally peer reviewed. Accepted: 20 July 2010 To share more people s experience of heart failure and heart transplantation go to: Heart_Failure The hunt for chemo wine I was diagnosed with a blood related cancer a few years ago, and I had six months of chemotherapy. I was given a thorough briefing on what to expect from the treatment by my haematologist, but I had not considered the impact it would have on my wine drinking. Many people who have chemotherapy lose their desire for alcohol, but I am too enthusiastic about wine to let cancer get between me and the grape. A week after my first chemotherapy session I developed a strange taste in my mouth. It was a mineral taste, a bit like clay, which coated the inside of my mouth. It changed and dulled the taste of many foods... and wine. I was warned off red wines because the tannins play havoc with the inside of your mouth stripping the cells, which are then destroyed by the chemotherapy, and leaving your mouth prone to ulcers. One bout of these ulcers was enough to put me off reds for the rest of my treatment, except for an almost tannin free 1982 Léoville Poyferré an exception for which I paid royally afterwards. I found that many of my favourite white wines tasted different, and I searched for a wine that would work for me. I was helped on this quest by my uncle. The hunt included sampling every white wine available by the glass on the list at The Garrick and a few that were not. It was extraordinary how much my taste had changed. My uncle and I usually have similar preferences when it comes to wine, but I found that wines I traditionally liked tasted different. I finally settled on two types of wine which suited the palette of my chemotherapy regimen: German Riesling and Hungarian Tokaji (5 puttonyos). My favourite Riesling was Egon Müller s Scharzhofberger from Mosel. The German wine is so light and fresh that it seemed to dance over my chemo mouth, and the cool temperature soothed it. The Royal Tokaji seemed to coat my mouth with honey, and the long aftertaste kept the taste of clay from coming back for a while I could make a glass last hours. Those wines had low levels of alcohol, which may have been relevant. My wine tasting quest was a wonderful diversion from the chemotherapy and its side effects. It gave me something light hearted to focus on. I gave my haematologist a bottle of the Riesling. He loved red wine and said that my present spurred him on to get me better so that I could revert to decent wine. It is now two years on since my treatment ended, and although I have reverted to drinking many of my pre chemo favourite wines, I have a special affection for Riesling, the most versatile of white grapes. We now drink it almost exclusively at home, and even after a year off the reds, my enthusiasm for them is undiminished. Jimmy Weir finance director, Egmont UK, London jweir@euk.egmont.com Cite this as: BMJ 2010;340:c649 BMJ 1 JANUARY 2011 VOLUME