Guidelines for the Safe Use of Procedural Sedation and Analgesia for Diagnostic and Therapeutic Procedures in Children: 2010

ISSN 1027-9148

Guidelines for the safe use of procedural sedation and analgesia for diagnostic and therapeutic procedures in children: 2010

Official supplement to:

The Official Journal of the South African Society of Anaesthesiologists

Southern African Journal of Anaesthesia and Analgesia

S Afr J Anaesthesiol Analg 2010:16(5)(Supplement 1):S1-S37 Foreword: Guidelines for procedural sedation and analgesia in children: 2010

Foreword

In clinical practice, the provision of sedation and analgesia Numerous other therapeutic groups have been consulted in to children has been managed by a variety of role players: this project, including paediatricians, paediatric radiologists, medical practitioners, nurses, dentists, and parents. These paediatric surgeons, emergency medicine specialists, guidelines, for paediatric procedural sedation and analgesia paediatric intensive care specialists, paediatric oncologists, (PSA) were prepared at the request of the Department of and sedation practitioners, and we thank them all for their Health of the Western Cape, after the importance of providing valuable contributions. children with safe sedation and analgesia was highlighted by the Provincial Coordinating Clinician for Anaesthesia. The emphasis of this document is on the provision of safe practice so that, regardless of whether the procedure is A group, convened by Dr Anthony Reed and including Prof undertaken in a physician’s office, a remote facility, or in Jenny Thomas, Prof James Roelofse and Drs Rebecca Gray, an operating room, all children are guaranteed the same Marianna de Kock, Jenna Piercy and Hannelie Schoemann, standard of care. It is an excellent source document for undertook the task of developing the guidelines. As the process subject definitions, and is based on information gained from unfolded, it became increasingly obvious that this document international and national peer-reviewed publications. This would be of benefit to the entire country, and would be in line with information is relevant to South African medical practice, and the international trend towards the formalisation of national acute the medications used are all available in this country. pain and sedation guidelines for both children and adults. The adult guidelines have already been published as a supplement This is the first edition of the paediatric procedural to the Southern African Journal of Anaesthesia and Analgesia sedation and analgesia guidelines and it should, therefore, (S Afr J Anaesthesiol Analg 2010;16(4)(Supplement 1):S1-S37), be regarded as a work in progress. The expectation is that and the acute pain guidelines are available as a pocket book. the document will be expanded and updated with each Both can be accessed online at www.sasaweb.com. future publication.

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Index

1. Introduction...... S1 2. Objectives of procedural sedation and analgesia...... S1 3. Definitions...... S1 3.1 General anaesthesia...... S1 Guidelines for the safe use of 3.2 Non-dissociative sedation...... S2 procedural sedation and analgesia 3.3 Dissociative sedation...... S2 3.4 Sedation end points...... S2 for diagnostic and therapeutic 3.4.1 Minimal sedation and anxiolysis...... S2 procedures in children: 2010 3.4.2 Moderate sedation and analgesia...... S2 3.4.3 Deep sedation and analgesia...... S2 Official supplement to: 3.5 Sedation techniques...... S2 advert 1/12/07 9:53 AM Page 1 3.5.1 Simple/basic sedation...... S2 The Official Journal of the South African Society of Anaesthesiologists 3.5.2 Advanced sedation...... S2 3.6 Failed sedation...... S2 Southern African Journal of Anaesthesia and Analgesia 3.7 American Society of Anesthesiologists Physical Status Classification...... S2 S Afr J Anaesthesiol Analg 2010:16(5)(Supplement 1):S1-S37 3.8 Active upper respiratory tract infection...... S3 4. Patient selection...... S3 PERFECTING THE ART OF SEDATION with sedation, analgesia and anxiolysis in a single agent with no respiratory depression.1,2,3 Available online at: 5. Pre-sedation patient assessment...... S3 6. Guidelines for fasting...... S5 Redefining sedation1 INDICATION: Sedation of initially intubated and mechanically ventilated post-surgical patients who have undergone routine cardiac surgery www.sajaa.co.za during treatment in an intensive care setting.1 References: 1. PreceDEX® package insert. 2. Maze M, Morrison P. Redefining sedation. International Congress and Symposium Series 221. Royal Society of Medicine Press Limited; 1998. 3. Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs 2000; 59(2): 263-268. Prescribing Information PRECEDEX (Dexmedetomidine HCl). Scheduling Status: S5 Pharmacological Classification:A 2.9 – Other Analgesics. Composition: Each 1 ml of concentrated solution contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine. Indications: Sedation of initially intubated and mechanically ventilated post-surgical patients who have undergone routine cardiac surgery during treatment in an intensive care setting. Dosage and Method of Use: Dosage should be individualized and titrated to the desired clinical effect. For administration by continuous intravenous infusion after dilution of PRECEDEX (2ml with 48 ml of 0,9% sodium chloride solution), using a controlled infusion device; not to exceed 24 hours. Fluid supplementation prior to and during administration is required. Refer to package insert for specific details. Side-Effects: Most frequently observed treatment-emergent adverse events: Hypotension, 7. Administration of off-label and unlicensed drugs in hypertension, bradycardia, dry mouth, nausea, somnolence and hypoxia. Refer to package insert for further details. Precautions: Continuous ECG, BP and oxygen saturation monitoring are mandatory during infusion. Pre-existing severe bradycardia disorders (ie. advanced heartblock), pre-existing severe ventricular dysfunction (eg. ejection fraction < 30%), including congestive heart failure and cardiac failure. Decreased blood pressure and/or heart rate may occur, which is most pronounced in patients with desensitized autonomic nervous system control ie. Ageing > 65 years of age, chronic hypertension, severe cardiac disease and in diabetic patients. Fluid supplementation prior to and during administration of PRECEDEX is required. Caution is required with co-administration of other vasodilators or negative chronotropic agents, due to additive effects of PRECEDEX. Potentiation of bradycardia or hypotension with propofol or midazolam. Transient hypertension with loading infusion of PRECEDEX. Reduced lacrimation. Enhancement of the effects of anaesthetics, sedatives, hypnotics and opioids, which may necessitate a reduction in the dose of these agents. Contra-Indications: Contra-indicated in patients with known hypersensitivity to dexmedetomidine, in patients with sepsis, unstable trauma patients, hypovolemic patients and in patients with heartblock or uncontrolled cardiac failure. Warnings:To be administered only by health professionals skilled in the management of patients in the intensive care setting following complete training in the use of PRECEDEX in the ICU setting. Safety and efficacy not established in non-surgical intensive care patients.Bradycardia and sinus arrest has occurred in young healthy volunteers with high vagal tone, or with different routes of administration including rapid IV or bolus administration. Safety in pregnancy has not been established. Careful dose titration with possible lower doses and close CVS monitoring of elderly patients, is required. Registration No: 34/2.9/0239 Name and Business Address of Licence Holder: Abbott Laboratories S.A. (Pty) Limited, Abbott Place, 219 Golf Club Terrace, Constantia Kloof, 1709 Please refer to the Scientific Package Insert for full prescribing information. Date of Publication of this Promotional Material: December 2006. 0009-1206-1638-A-0258 12.06 paediatric practice...... S5 8. Drugs used in procedural sedation and analgesia...... S5 © Copyright 2010: The South African Society of Anaesthesiologists (SASA). 8.1 Sedatives...... S5 8.1.1 Benzodiazepines...... S5 8.1.1.1 Midazolam...... S5 8.1.1.2 Flumazenil...... S6 8.1.2 Anaesthetic agents...... S6 8.1.2.1 Ketamine...... S6 This work is licensed under a 8.1.2.2 Propofol...... S7 Creative Commons Attribution- 8.1.2.3 Ketofol...... S7 Noncommercial-No Derivative Works 2.5 South Africa License. 8.1.3 Alpha-agonists...... S7 http://creativecommons.org/licenses/ 8.1.3.1 Clonidine...... S8 by-nc-nd/2.5/za/ 8.1.3.2 Dexmedetomidine...... S8 8.1.4 Other sedative agents...... S8 Enquiries: [email protected] or ...... S8 [email protected] or SASA, 8.1.4.1 Chloral hydrate and trichlorphos PO Box 1105, Cramerview, 2060, 8.1.4.2 Trimeprazine...... S8 Gauteng, South Africa. 8.1.4.3 Droperidol...... S8 8.2 Analgesics...... S8 8.2.1 Opioids...... S8 Disclaimer 8.2.1.1 Tilidine...... S9 This is an official consensus document 8.2.1.2 Fentanyl and alfentanil...... S9 of the South African Society of 8.2.1.3 Remifentanil...... S9 Anaesthesiologists (SASA). Whilst every effort has been made to ensure scientific 8.2.1.4 Naloxone...... S9 accuracy, SASA and Medpharm shall not 8.2.2 Nitrous oxide...... S9 be held responsible or in any way liable for errors, omissions or inaccuracies in this 8.2.3 Simple analgesics...... S10 publication, whether arising from negligence 8.2.4 Local anaesthetics...... S10 or otherwise or for any consequences 9. Environment and clinical setting...... S10 arising therefrom. 10. Monitoring...... S10 11. Discharge...... S12 11.1 Discharge criteria: from the recovery area to the ward....S12 MEDPHARM 11.2 Discharge criteria: from the health care facility to PUBLICATIONS Published by Medpharm Publications home...... S12 (Pty) Ltd 12. Documentation required during procedural sedation and www.medpharm.co.za analgesia...... S13 12.1 Documentation before sedation...... S13

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12.2 Documentation immediately before sedation...... S13 12.3 Documentation during sedation...... S13 12.4 Documentation after sedation...... S13 13. Adverse events accompanying procedural sedation and analgesia...... S14 14. Procedure-specific recommendations...... S14 14.1 Psychological preparation of children for procedures...... S14 14.2 Acute pain control and sedation for specific procedures...... S15 14.2.1 Dental procedures...... S15 14.2.2 Medical procedures...... S16 14.2.2.1 Procedural pain in the neonate...... S16 14.2.2.1.1 Blood sampling and intravenous cannulation...... S16 14.2.2.1.2 Heel prick (lancing)...... S16 14.2.2.1.3 Percutaneous central venous catheter. insertion...... S16 14.2.2.1.4 Ocular examination for retinopathy . of prematurity...... S16 14.2.2.1.5 Lumbar puncture...... S16 14.2.2.1.6 Urine sampling...... S17 14.2.2.2 Procedural pain in older children...... S17 14.2.2.2.1 Blood sampling and intravenous cannulation...... S17 14.2.2.2.2 Lumbar puncture...... S17 14.2.2.2.3 Urine sampling...... S17 14.2.2.2.4 Insertion of a nasogastric tube...... S17 14.2.3 Surgical procedures...... S17 14.2.3.1 Neonatal circumcision...... S17 14.2.3.2 Circumcision of the older child...... S17 14.2.3.3 Bone marrow trephine biopsy...... S17 14.2.3.4 Chest drain insertion and removal...... S17 14.2.3.5 Burns: changing dressings...... S17 14.2.4 Procedures in the trauma and emergency unit...... S18 14.2.4.1 Laceration repairs...... S18 14.2.4.2 Fracture manipulation...... S18 14.2.5 Procedures in the radiology suite...... S18 14.2.5.1 Magnetic resonance imaging, computed. tomography and ultrasound...... S18 14.2.5.2 Painful radiological procedures...... S19 14.2.5.2.1 Intussusception reduction...... S19 14.2.5.2.2 Cardiac catheterisation...... S19 15. Setting up a sedation service...... S19 15.1 Environment, patient selection and patient assessment.....S20 15.2 Training requirements...... S20 15.3 Sedation practitioner: experience...... S20 15.4 Sedation practitioner: ability to rescue...... S20 15.5 Record keeping...... S20

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Appendices

Appendix 1: Medical history questionnaire...... S21 Appendix 2: Consent to sedation and analgesia for medical/dental procedures...... S23 Appendix 3: Pre- and post-sedation instructions...... S24 Appendix 4: Clinical monitoring for paediatric sedation...... S26 Appendix 5a: Sedation monitoring chart...... S27 Appendix 5b: Post-sedation monitoring chart...... S28 Appendix 5c: Discharge scoring system...... S29 Appendix 5d: Discharge questionnaire...... S30 Appendix 6: Drug dosage tables...... S31 Appendix 7: Checklist of equipment required for paediatric procedural sedation and analgesia...... S34 Appendix 8: Paediatric pre-procedural checklist...... S35 Appendix 9: Critical incident reporting form: paediatric procedural sedation and analgesia...... S36

Alphabetical list of drugs

• Alfentanil...... S9 • Bupivacaine...... S9 • Chloral hydrate...... S10 • Clonidine...... S8 • Dexmedetomidine...... S8 • Diclofenac...... S10 • Droperidol...... S10 • EMLA®...... S10 • Fentanyl...... S9 • Flumazenil...... S6 • Ibuprofen...... S10 • Ketamine...... S6 • Ketofol...... S7 • Ketorolac...... S10 • Lignocaine...... S10 • Midazolam...... S5 • Naloxone...... S9 • Nitrous oxide...... S9 • Paracetamol...... S10 • Propofol...... S7 • Remifentanil...... S9 • Tilidine...... S9 • Trichlorphos...... S8 • Trimeprazine...... S8

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Tables

Table I: ASA Physical Status Classification System...... S2 Table II: Specific airway factors that necessitate sedation in the hospital setting...... S4 Table III: Single agent dosing schedule of midazolam...... S6 Table IV: Dosing schedule of flumazenil...... S6 Table V: Dosing schedule of ketamine...... S7 Table VI: Single agent dosing schedule of propofol...... S7 Table VII: Dosing schedule of ketofol, consisting of ketamine 5 mg/ml and propofol 9 mg/ml...... S7 Table VIII: Single oral agent dosing schedule of clonidine...... S8 Table IX: Dosing schedule of chloral hydrate...... S8 Table X: Dosing schedule of trimeprazine...... S8 Table XI: Dosing schedule of droperidol...... S8 Table XII: Dosing schedule of tilidine...... S9 Table XIII: Single agent dosing schedule of fentanyl...... S9 Table XIV: Single agent dosing schedule of alfentanil...... S9 Table XV: Dosing schedule of naloxone...... S9 Table XVI: Dosing schedule of nitrous oxide...... S10 Table XVII: Dosing schedule of simple analgesics...... S10 Table XVIII: Maximum safe doses of local anaesthetic drugs...... S10 Table XIX: Checklist of equipment required for paediatric PSA...... S11 Table XX: Discharge scoring system...... S12 Table XXI: Discharge questionnaire...... S12

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Guidelines for the safe use of procedural sedation and analgesia for diagnostic and therapeutic procedures in children: 2010

All health care professionals participating in the administration, monitoring and recovery of patients requiring procedural sedation and analgesia (PSA) or general anaesthesia are accountable for safe practice. The patient is entitled to the same standards of care, whether the procedure is undertaken in a physician’s office, a remote facility, or an operating theatre.

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1. Introduction • Patients requiring intensive care sedation. • Prescription of sedation for palliative care. “The safe sedation of children requires a protective net • Sedation in the home setting. composed of skilled personnel, vigilance, monitoring • Premedication for patients undergoing general anaes- equipment, common sense in selecting patients suitable for thesia. sedation, appropriate selection of drugs and drug dosage, age • Night sedation. and size appropriate airway management equipment, and drugs to sustain life. Seizures, respiratory arrests, and deaths 2. Objectives of procedural sedation and analgesia in a variety of practice settings have occurred when any one of these was deficient.” PSA must provide a safe environment for the patient, and the (Charles J Coté, MD) result must be effective control of pain, anxiety and movement in children undergoing procedures. Decreased awareness and The aim of this document is to provide a reference that will amnesia are added advantages. enable all practitioners to act within a framework to ensure patient safety and the successful performance of procedures. In some circumstances, a short general anaesthetic may provide a quicker, more controllable, more reliable and safer These guidelines are intended for use by all medical option for the completion of the procedure/investigation. practitioners in order to provide safe sedation, analgesia and This would require appropriate skills, monitoring and anxiolysis for children in all environments. Identification of environment. those children unsuitable for PSA is crucial, and many of the sedation techniques utilised in adults are not recommended 3. Definitions for paediatric practice. The definition of PSA encompasses a continuum of altered These guidelines will: state of consciousness,varying from minimal sedation and anxiolysis to deep sedation. • Define the terms used in PSA. • Provide guidance on appropriate patient selection. The response that individual patients will have to the • Discuss drugs recommended for PSA. administration of sedatives is difficult to predict. The drugs • Specify equipment essential for PSA. used, the dosages administered, the additive effects of • Provide recommendations for monitoring, based on the concomitant drugs and the patient’s pharmacogenetic profile sedation method utilised. will all impact on the depth of sedation. An unexpected • Specify discharge criteria after PSA. progression of the depth of sedation must therefore be • Provide examples of the recommended documentation to anticipated, and practitioners must be able to rescue patients complete and keep before, during and after PSA. who enter a deeper level of sedation than intended. • Provide examples of PSA regimens for a variety of clinical scenarios. If the patient fails to respond to verbal commands and/or light touch, the standard of care must be identical to that for general Attention to environmental factors is essential for the safe anaesthesia. Guidelines for the care of the anaesthetised practice of PSA, and is also a basic requirement for ensuring patient are provided in the publication Guidelines for Practice a satisfactory outcome for both the patient and the procedure. issued by the South African Society of Anaesthesiologists It is recommended that an annual audit of the procedures (SASA), and are not addressed in this document. performed be conducted, and that this process includes a review of all critical adverse events. 3.1 General anaesthesia

These guidelines are applicable to paediatric patients General anaesthesia is a drug-induced loss of consciousness undergoing painful or non-painful diagnostic or therapeutic during which patients cannot be roused, even by painful procedures, and are not applicable to: stimulation. The ability to maintain independent ventilatory

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function is impaired. Patients require assistance in maintaining 3.5 Sedation techniques a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation 3.5.1 Simple/basic sedation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Simple/basic sedation is induced by a single agent and not a combination of single agents, for example: 3.2 Non-dissociative sedation • Oral, transmucosal or rectal drugs, e.g. a small dose of an Non-dissociative sedative drugs (including opioids, benzo- oral benzodiazepine; or

diazepines, barbiturates, etomidate and propofol) operate • Inhalation of nitrous oxide (N2O) in at least 50% oxygen. on the sedation dose-response continuum. Higher doses provide progressively deeper levels of sedation with Sedation can no longer be considered simple or basic once possible respiratory and cardiovascular compromise, additional agents become necessary, and the depth of central nervous system depression, and unconsciousness. sedation may not be advanced unless the patient is fasted. With the use of non-dissociative drugs, the key to minimising adverse events is the careful titration of drugs 3.5.2 Advanced sedation to the desired effect. Advanced sedation is induced by one of the following 3.3 Dissociative sedation techniques:

Dissociative sedation, produced by ketamine, causes • Any combination of drugs, administered by any route; or a trance-like cataleptic state characterised by intense • Any sedation administered by the intravenous route, analgesia, amnesia, sedation, retention of protective reflexes using bolus or infusion techniques; or (as deeper levels of sedation are reached, airway reflexes • Any inhalational sedation (e.g. sevoflurane), with the

may be obtunded), spontaneous breathing and cardiovascular exception of N2O used as the sole agent in a concentration stability. It is believed that, when ketamine is administered of less than 50% in oxygen. in dissociative doses, it does not operate on the sedation continuum. Advanced sedation can include both dissociative and non- dissociative techniques. 3.4 Sedation end points 3.6 Failed sedation 3.4.1 Minimal sedation and anxiolysis Failed sedation is defined as the failure to achieve the desired Minimal sedation is a drug-induced state during which the level of sedation, such that the procedure has be abandoned, patient responds normally to verbal commands. Cognitive or the need arises to convert to general anaesthesia. Possible function may be impaired, but ventilatory and cardiovascular reasons for failure include patient factors, drug factors, or functions are unaffected. procedure-related and operator factors. A previous episode of failed sedation will necessitate that the child be carefully 3.4.2 Moderate sedation and analgesia assessed, and consideration be given to the provision of general anaesthesia, rather than sedation, for future Moderate sedation is a drug-induced depression of procedures. consciousness during which the patient responds purposefully to verbal commands, either alone or accompanied by light, 3.7 American Society of Anesthesiologists Physical Staus tactile stimulation. No interventions are required to maintain a Classification patent airway and spontaneous ventilation is adequate. The American Society of Anesthesiologists (ASA) Physical 3.4.3 Deep sedation and analgesia Status Classification System is tabulated below (Table I):

Deep sedation is a drug-induced depression of Table I: ASA Physical Status Classification System consciousness during which the patient cannot easily be roused, but may respond purposefully following repeated or painful stimulation. (Reflex withdrawal from a painful Class I A normally healthy patient stimulus is not considered a purposeful response.) The Class II A patient with mild systemic disease and no functional patient may require assistance in maintaining a patent incapacity airway and spontaneous ventilation may be inadequate. Class III A patient with severe systemic disease that limits activity, Cardiovascular function is usually maintained. but is not incapacitating

Class IV A patient with severe systemic disease that is a constant threat to life In accordance with the Guidelines for Practice issued by SASA, deep sedation is considered part of the spectrum Class V A moribund patient not expected to survive 24 hours with or without an operation of general anaesthesia, and should only be performed by those with anaesthetic training. “E” An emergency procedure is denoted by the letter E following the class number

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3.8 Active upper respiratory tract infection ditions predisposing to reflux. • Active vomiting. An active upper respiratory tract infection (URTI) is a current or • Haematological conditions, including coagulation dis- recent upper respiratory tract infection, where two or more of orders and sickle cell disease. the following symptoms or signs are still present: • ASA class III and IV. • Parental reluctance. • Rhinorrhoea • Children with malignancies. • Sore or scratchy throat • Sneezing In other patients, the sedationist should be more cautious and • Nasal congestion have a low threshold for referring the patient to a more suitable • Malaise institution, if he or she does not feel comfortable performing • Cough the sedation. In these patients, even simple sedation may be • Fever problematic: • Unexplained tachycardia • If a parent reports or is concerned that the child is sick • Age < 5 years. • Acute or chronic altered mental state. 4. Patient selection • Head injury. • Communication problems. No patient should be considered for sedation without a • Autism. thorough assessment of the airway. • Severely delayed physical or mental milestones. • Children on psychotropic drugs, including methylphe- ASA class I and II patients are usually good candidates for nidate. sedation. • Epilepsy. • Controlled gastro-oesophageal reflux (i.e. GORD on No children under five years of age should be sedated by treatment). practitioners who do not have extensive experience in the practice of sedation of young children. 5. Pre-sedation patient assessment

Certain patients are at increased risk for complications and Before sedation, a health evaluation should be performed on should at least be assessed by a specialist anaesthesiologist every child by an appropriately trained sedation practitioner. (or a highly experienced sedation practitioner) who need not The ability to communicate with the child is essential, and be the sedationist, but will be available for consultation and, identification of those children unsuitable for sedation is preferably, assistance. These patients should preferably be crucial. sedated in a hospital setting: It is useful to record the pre-sedation assessment on the pre- • Age < 1 year. sedation medical history questionnaire (Appendix 1), as well • Prematurity with residual pulmonary, cardiovascular, as on the sedation monitoring chart (Appendix 5a). gastrointestinal or neurological problems, or significant anaemia. This evaluation should include an assessment of: • Children with congenital syndromes. • Obesity (> 95th percentile body mass index (BMI) for age). • Age: caution with children < 5 years. • Children who need an advanced sedation technique. • A previous failed sedation. • Weight: appropriate for age. • A previous oversedation (unintentional deep sedation or general anaesthesia). • Birth and neonatal history. • Any known adverse effect (hyperactive or paradoxical response) or allergy to any of the sedation drugs. • Prematurity. • Any child who, following airway assessment (see table II), is suspected of having airway problems. • Fasting status. • Children with respiratory problems, including an active URTI, low oxygen saturation, and a weak cough or cry. • Full medical history: • Asthmatic children who are clinically wheezing or whose −− Relevant diseases, physical abnormalities, con- regular treatment includes more than inhalational short- genital syndromes.

acting ß2–agonists and inhalational steroids. −− Behavioural problems, hyperactivity, mental retar- • Children with cardiac problems, including congenital dation. cardiac disease, cyanosis, congestive heart failure and −− Previous relevant hospitalisation. undiagnosed murmurs. −− Previous negative experience (e.g. pain or necessity • Neurological conditions, including poorly-controlled for restraint) in any medical/dental facility. seizures, neuromuscular disease, central apnoea or an −− History of sedation or general anesthesia and any unstable cervical spine. complications, including previous failed sedation. • Increased intracranial pressure. −− Allergies and previous allergic or adverse drug • Severe behavioural problems. reactions. • Uncontrolled gastro-oesophageal reflux or other con- −− Medication (e.g. anti-epileptic drugs, antiretroviral

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drugs): -- Neck: -- Drug used, including dosage, time and route -- Flexion and extension. and site of administration of prescription drugs, -- Thyromental distance (distance more than over-the-counter drugs, herbal preparations or the width of the three middle fingers of the illicit drugs. child). −− Family history (e.g. porphyria, previous reaction to −− Respiratory system: anaesthetic drugs). -- Increased respiratory rate. −− Risk of aspiration: -- Use of accessory muscles. -- Reflux/regurgitation. -- Stridor. -- Patient not fasted (e.g. emergency procedure, -- Hoarseness. trauma). -- Audible wheezing. -- Productive cough. • Review of organ systems: -- Clubbing. −− Respiratory system: -- Cyanosis. -- Recent respiratory tract infection. −− Cardiovascular system: -- Snoring, apnoea. -- Cyanosis. −− Cardiovascular system: -- Signs of heart failure. -- Activity level of child (effort tolerance). -- Presence of a murmur; further assessment will -- Congenital cardiac disease (heart murmur, be needed. cyanosis). −− Behavioural problems or developmental delay. Table II: Specific airway factors that necessitate sedation in the −− Congenital abnormalities and syndromes. hospital setting

• Physical examination: • Obstructive sleep apnoea (OSA) −− Vital signs, including heart rate, blood pressure, • Large tonsils approaching the midline, or associated with loud respiratory rate and temperature. snoring General examination. • Children who cannot lie flat because of airway obstruction −− • Stridor −− Airway assessment: • Retropharyngeal masses -- Observe from the front and side (lateral view) • Neck masses for abnormalities of the face, mouth, nose • Tracheal deviation and neck, looking for particularly syndromic • Mallampati class 3 or 4 • Neck mobility: decreased range of movement, including features: hydrocephalus with a large head -- Low-positioned or abnormal ears. • Syndromic features (e.g. Pierre-Robin, Treacher-Collins): -- Facial (preauricular) tags. -- Enlarged tongue -- Hypoplastic or receding chin. -- Micrognathia -- Upper jaw overbite. -- Abnormal ears • Haemangiomas -- Lymphoid hyperplasia. • Beware of children with malignancies: multiple level airway -- Mouth opening (three fingers of the child can obstruction is possible be inserted): -- Loose teeth. -- Enlarged tongue. The evaluation must conclude with a risk assessment, as -- Inspection of the pharynx: there may be factors (e.g. airway problems or obesity) that -- Enlarged tonsils (approaching the midline place the child at an increased risk. These patients may or associated with snoring). warrant additional consultation or referral before sedation -- Mallampati classification (Figure 1). (see Section 4).

Figure 1: Mallampati classification for prediction of difficult intubation.

Class 1 Class 2 Class 3* Class 4*

*Class 3 and 4 not for sedation outside the hospital setting (Diagrams by Helene Loon)

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Record the name, address and telephone number (including • Children may be harmed if administered drugs which an after-hours number) of the child’s general practitioner or have not been adequately tested. clinic. • If extrapolated from adult doses, doses meant for children may be inadequate or toxic. Once it has been decided to proceed with sedation, • The higher basal metabolic rate, organ immaturity, and appropriate informed consent should be obtained from a pharmacodynamic and pharmacokinetic profiles of responsible person (Appendix 2). This person could be the children may differ from adults. parent or guardian. Instructions and information should be provided to the responsible person. If use of suppositories/ Health care professionals looking after children: rectal medication is planned, it is recommended that consent should be obtained for this. • Are responsible for choosing the appropriate drug and dose. 6. Guidelines for fasting •• Are required to motivate and substantiate these choices by referring to international literature and guidelines. When simple sedation techniques (see Section 3) are planned, no •• Should only make drug choices after considering: fasting is necessary. −− Sound scientific data; • −− Expert judgment;

When N2O (≤ 50%) is administered alone, no fasting is −− Professional literature. necessary. The unlicensed or off-label use of medications is a common If advanced techniques (including dissociative and non- practice worldwide, and the situation in South Africa is no dissociative techniques) and/or deep sedation (see Section 3) different. This is particularly relevant to paediatric practice, are planned, standard anaesthetic fasting guidelines should especially where neonates and infants are concerned . be applied: Doctors are at risk of litigation when prescribing unlicensed • Clear fluids: two hours. and off-label drugs for their small patients, but can defend • Breast milk: four hours. themselves by referring to international literature and guidelines. • Formula feeds and solid food: six hours. The package inserts of drugs are not medicolegal documents.

Children should not have to fast for unnecessary lengths of 8. Drugs used in procedural sedation and analgesia time. Clear fluids should be administered up to two hours before the procedure. A “clear fluid” is defined as fluid Many of the maximum doses recommended here are lower which is non-particulate, and through which newsprint is than those quoted in the respective package inserts. This is visible. because PSA frequently involves the administration of more than one type of drug. Drugs for PSA are synergistic when In urgent cases, when a procedure cannot be postponed used in combination and it is mandatory that the doses be and simple sedation techniques are deemed unsuitable, a reduced accordingly, and titrated to effect in divided doses. general anaesthetic with rapid sequence induction should be The sum of the incremental doses must not exceed the considered. recommended maximum dose.

7. Administration of off-label and unlicensed drugs in When administering drugs for PSA, the sedation practitioner paediatric practice must remember that there is no fixed dose, only a maximum dose. Off-label drug use: The use of licensed medicines outside the conditions of licence. A summary of the drug tables is available in Appendix 6.

Unlicensed drug use: The use of pharmaceutical products 8.1 Sedatives that have not been approved by any licensing authority of a specific country. 8.1.1 Benzodiazepines

In paediatric practice, in particular, the use of unlicensed drugs 8.1.1.1 Midazolam is common, and the preparation of drugs by non-pharmacists occurs frequently. This has resulted in the administration of Midazolam is a short-acting benzodiazepine with sedative, medication “cocktails” in clinical practice. anxiolytic, amnestic and anticonvulsant properties. It has no analgesic effect. Used in the recommended doses (Table III), The problem exists because the testing of drugs in clinical the administration of midazolam should result in a conscious, trials in children presents a dilemma: should children be compliant child. spared the potential risks associated with clinical research? And, also, is there enough incentive for pharmaceutical When administered in combination with other depressant drugs companies to invest in the relatively small market for drugs (particularly opiates, with which midazolam has a super-additive developed for administration to neonates and infants? effect), or used on its own in higher than recommended doses, midazolam is likely to result in the loss of upper airway muscle But, the counterarguments to this line of thinking are that: tone with obstruction. Respiratory and cardiac depression are

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also possible consequences. Children predisposed to upper the child should be carefully monitored for at least two airway obstruction are particularly at risk. hours, with a view to repeating the flumazenil dose. In an emergency, if intravenous access is not available, the Paradoxical agitation occurs in up to 15% of patients. Giving intravenous dose may be given intranasally. additional doses of midazolam in attempt to control the child will merely exacerbate the symptoms, until unconsciousness In patients who are taking benzodiazepines for seizures or and severe respiratory depression are induced. In such cases, behavioural disturbances, administration of flumazenil may an alternative agent should be used. Ataxia, dystonia and precipitate these symptoms. diplopia are other possible adverse effects associated with midazolam use. Table IV: Dosing schedule of flumazenil

Intranasal administration is not recommended, as it causes Dose Titration Maximum Duration of a burning pain and leaves a bitter aftertaste that may last for interval dose action several days. Rectal administration could be considered in 10 µg/kg over 2 minutes* 1 mg/kg 1 hour young children, but absorption may be unpredictable. Rectal 30 seconds administration may also be preferred in children who refuse oral medication. Parental consent should always be sought * Repeat dose until desired effect achieved, or recommended maximum dose prior to administering medication via the rectal route. A reached paediatric feeding tube can be used to administer midazolam rectally. Intramuscular administration is painful and is not 8.1.2 Anaesthetic agents recommended.

Table III: Single agent dosing schedule of midazolam 8.1.2.1 Ketamine The multiple actions and cardiovascular stability of Route of Dose Recommended Time to Duration ketamine administration maximum dose peak of make it a very useful agent for painful procedures. It induces effect action a state of cortical dissociation with profound analgesia, Oral 0.25–0.5 7.5 mg 10–30 60 sedation and amnesia. Ketamine is sometimes associated mg/kg minutes minutes* with non-purposeful movements, which limits its use when Sublingual 0.25–0.3 0.3 mg/kg 10–15 20-60 total immobility is required (e.g. for CT or MRI scans). mg/kg minutes minutes* Intravenous 0.025–0.1 mg/ 1 mg 3–5 20-60 Compared with other anaesthetic agents, there is relative kg** minutes minutes* preservation of airway reflexes and tone. However, as increasing doses are given, this cannot be relied upon. Rectal 0.5–0.75 1 mg/kg 10–20 60 Airway observation remains an essential part of monitoring. mg/kg minutes minutes* Hypercarbia may occur with ketamine, particularly in the face Intranasal 0.2–0.3 mg/kg 0.3 mg/kg 10–15 60–120 of airway obstruction. minutes minutes* Prophylactic co-administration of an antisialogogue (atropine When used in combination with other drugs, doses should be decreased and 0.02 mg/kg orally or intravenously, or glycopyrrolate titrated to effect 0.01 mg/kg intravenously) is recommended to diminish the * Dose-related ** production of tracheobronchial secretions and saliva. The Titrate to effect, repeat dose every five minutes until desired level of production of secretions can be particularly problematic in the sedation achieved presence of an URTI and will predispose to laryngospasm. The intravenous formulation can be given orally, mixed in a small volume of juice, cold drink or paracetamol syrup to The emergence delirium associated with ketamine in disguise the bitter taste. Once mixed, the shelf life is less than adults is less common in children, and of a much smaller 24 hours. To improve palatability, tablets can be crushed and magnitude. It correlates significantly with the degree of premixed in the same way. procedural agitation. Midazolam can be co-administered (0.05–0.2 mg/kg orally) to reduce the incidence further, When given intravenously, most children should require no but this will deepen and prolong sedation and increase the more than 1mg and, in combination with other depressant likelihood of apnoea. drugs, ≤ 0.5 mg is recommended. The sympathomimetic action of ketamine may result in a 8.1.1.2 Flumazenil tachycardia and hypertension, but this is usually not seen in sedative doses. Flumazenil, the benzodiazepine antagonist, reverses the sedative and respiratory depressant effects of midazolam, Ketamine should be used with caution in children with head and should be readily available whenever midazolam is used or eye injuries, as it may cause an increase in intracranial and (Table IV). intraocular pressure. This may be exacerbated in the presence of hypercarbia. The duration of action is approximately one hour and, if large doses of midazolam have been administered, Other reported reactions (ataxia, nystagmus, myoclonus, random resedation may occur after this point. In such cases, limb movements and opisthotonus) are rarely clinically important.

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Table V: Dosing schedule of ketamine more likely to be associated with adverse events. The use of capnography is highly recommended when propofol is used Route of Dose Onset of Time to Duration for sedation, due to the relatively high incidence of respiratory administration action peak of action depression and airway obstruction. Supplemental oxygenation effect may mask this adverse event if oxygen saturation alone is Sedation monitored. > 5 30 Oral 6-10 mg/kg 4–6 hours minutes minutes* In up to 90% of cases, propofol causes pain on injection. Intravenous < 1 3–5 10-15 Combination with lignocaine (0.1 ml 2% lignocaine/ml of 0.25–1 mg/kg** (bolus) minute minutes minutes propofol) will reduce this. Intravenous 0.5–1 mg/kg/ < 1 3–5 10-15 (infusion) hour*** minute minutes minutes Prolonged infusions (> 18 hours at > 4 mg/kg/hour) have 2–5 20 30–120 been associated with fatal metabolic acidosis. Intramuscular 2-4 mg/kg minutes minutes minutes* > 5 30 30–120 Propofol has no analgesic properties and, if a painful Rectal 4–6 mg/kg minutes minutes* minutes* procedure is planned, an appropriate analgesic agent should Analgesia also be given. > 5 30 Oral 4–6 mg/kg 4–6 hours minutes minutes* Table VI: Single agent dosing schedule of propofol Intravenous 0.15–0.3 mg/ < 1 3–5 15 (infusion) kg/hr minute minutes minutes Dose Onset of Duration of Repeat Titration action action dose interval * Dose-related 0.3–0.5 mg/kg 45–90 5 – 8 0.5 mg/kg 1 minute ** Titrate to effect, repeating dose every three minutes until desired level of seconds minutes sedation achieved *** Infusion following bolus dose of 0.25–1 mg/kg 8.1.2.3 Ketofol

Ketamine, as a single agent, can be used at subhypnotic “Ketofol”, a combination of ketamine and propofol, is doses to achieve an analgesic effect. emerging as a useful drug combination in PSA. There is synergism between propofol and ketamine, and combination Ketamine can be given via multiple routes (Table V), including therapy allows the use of lower doses of both drugs, thereby intranasally. But, as with most other drugs, this route is not decreasing the likelihood of side effects. recommended, as it can be very distressing for the child. Used alone, this combination is adequate for minor medical When used in combination with other sedative agents, and and dental procedures. More painful procedures will require to decrease the likelihood of complications (respiratory deeper levels of sedation, or the addition of further agents, depression and airway obstruction), the dose of ketamine such as local anaesthetic. should be halved. The recommended preparation of ketofol for paediatric use 8.1.2.2 Propofol is 50 mg ketamine with 90 mg propofol diluted to 10 ml. This results in a concentration of 5 mg/ml ketamine and 9 mg/ml propofol and, of this solution, 0.05 ml/kg is Propofol is a short-acting, intravenously administered sedative hypnotic that can be used in small boluses titrated to effect recommended (Table VII). (Table VI), or as a continuous infusion. Both agents can have side effects, and airway vigilance is Propofol is a controversial drug outside the operating theatre. essential. While it is an effective agent, propofol has a narrow margin of safety when Table VII: Dosing schedule of ketofol, consisting of ketamine 5 mg/ml and propofol 9 mg/ml compared with the other sedatives outlined in these guidelines (midazolam, Route of Dose Onset of Duration of Repeat dose Titration ketamine, clonidine, chloral hydrate administration action action interval and trimeprazine). Deep sedation, 30–90 Intravenous 0.05 ml/kg* 5–10 minutes 0.05 ml/kg 1–5 minutes airway obstruction and apnoea occur seconds rapidly and unpredictably. Children are particularly sensitive to repeated * Ketamine 0.25 mg/kg and propofol 0.45 mg/kg. boluses of propofol.

Propofol should only be administered by an experienced 8.1.3 Alpha-agonists sedationist with anaesthetic training, who is skilled in the airway management of children, and in a facility that meets Alpha-agonists are sedative analgesics with anxiolytic, but all of the criteria laid out in these guidelines. It should only be no amnestic, effects. When used in the recommended doses used for brief procedures, as repeated doses or infusions are as single agents, these drugs have little to no respiratory

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depressant effects. Oral agents are particularly useful in 8.1.4.2 Trimeprazine combination with simple analgesics for painful procedures. Trimeprazine (Vallergan®), also known as alimemazine, is a 8.1.3.1 Clonidine long-acting phenothiazine derivative which may be used on its own or in combination with other sedatives (e.g. droperidol). Clonidine can be administered via multiple routes but, It is available in oral form and, due to erratic absorption, the for the purposes of procedural sedation, the oral route is onset time is variable (Table X). The long duration of action recommended (Table VIII). of trimeprazine makes it unsuitable for the out-patient or ambulatory setting. Table VIII: Single oral agent dosing schedule of clonidine Side effects include dry mouth, sweating, tachycardia, fever, Dose Onset of action Time to peak effect rash, convulsions and coma. Rarely, instances of paradoxical 1 – 5 µg/kg 20 – 40 minutes 60 minutes excitation have been described. Table X: Dosing schedule of trimeprazine 8.1.3.2 Dexmedetomidine Dose Onset of action Duration of action

Dexmedetomidine is a more selective α2-agonist, administered 1–2 mg/kg 60–90 minutes 5–8 hours primarily by intravenous infusion. Its use is only recommended by those highly experienced in paediatric sedation, and with anaesthetic training. 8.1.4.3 Droperidol

8.1.4 Other sedative agents Droperidol is a butyrophenone with sedative and antiemetic, but no anxiolytic, properties. Dysphoria and a “locked-in” 8.1.4.1 Chloral hydrate and trichlorphos feeling are more likely to occur if it is prescribed alone. For this reason, droperidol should only be used in combination Chloral hydrate is one of the oldest sedative hypnotic drugs with other sedatives, such as trimeprazine. available. It has no analgesic properties, and should be used for non-painful procedures only. Trichlorphos is structurally Droperidol may be administered by the oral or intravenous similar and can be used interchangeably with chloral hydrate. routes (Table XI). It is a very effective antiemetic in low doses, Chloral hydrate and trichlorphos are only available in oral form. with no associated sedation. Higher doses of the intravenous form, usually used in the setting of psychosis, have been In the recommended doses (Table IX), chloral hydrate is associated with prolongation of the QT interval and cardiac considered safe, although respiratory depression and airway arrest. obstruction can occur in predisposed patients. When higher doses (≥ 75 mg/kg) are used, or when chloral hydrate is For the sedation of children, only the oral route is recommended, combined with other depressant drugs, this is more likely. and then in combination with trimeprazine. Other adverse effects include gastric irritation, nausea and vomiting. These effects are lessened by administration with Because of its long duration of action, droperidol is not food or water. Chloral hydrate has been shown to be more recommended for sedation for out-patient procedures. effective when taken on a full stomach. Table XI: Dosing schedule of droperidol The combination of chloral hydrate with other agents is not recommended. Route of Dose Duration of action administration The sedative effects of chloral hydrate are unreliable over the age of three years. In toddlers and infants, its duration Sedation of action may be prolonged. The degree of sedation is dose Oral 0.05–0.2 mg/kg 2–6 hours dependent. Post-procedural monitoring must continue until the level of sedation, without stimulation, is clearly decreasing. Antiemesis In premature infants, the duration of action will be significantly Oral or intravenous 10–20 μg/kg 6 hours prolonged and respiratory depressant effects will be evident at lower doses. It is not recommended for use in this group of patients. 8.2 Analgesics

Chloral hydrate is contraindicated in patients with porphyria. 8.2.1 Opioids Table IX: Dosing schedule of chloral hydrate Opioids are analgesic drugs that can induce varying degrees of sedation and respiratory and cardiac Dose Maximum Onset of Time to Duration depression, particularly when used in combination with dose action peak effect of action other respiratory depressant drugs (e.g. midazolam). 25–100 mg/kg 2 g 15–30 30–60 6–8 hours Opioids are not primarily sedative drugs, and the sedative minutes minutes action is a side effect.

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8.2.1.1 Tilidine Alfentanil has a rapid onset and short duration of action, making it useful for short painful procedures. It should Tilidine (Valoron®) is an intermediate-acting opiate available be titrated until the desired level of analgesia is reached in droplet form. One droplet contains 2.5mg of the active (Table XIV). If the procedure is expected to take longer than ingredient. Tilidine is a sublingually administered opioid, with two minutes, an infusion should be initiated. This should be a side effect profile common to this group of drugs. It has terminated at the conclusion of the procedure. a bitter taste and is best administered under the tongue or just inside the tooth margins. In bigger children, where the Table XIV: Single agent dosing schedule of alfentanil body weight is excessive for age, the dose of a “drop per year of age” may be used as a guide, and titration to effect is Intravenous Titration Duration of Infusion dose recommended (Table XII). bolus dose interval action 0.5–1 µg/kg 2 minutes < 5 minutes 10–12 µg/kg/hour Table XII: Dosing schedule of tilidine

8.2.1.3 Remifentanil Dose Time to peak effect Duration of action 1 mg/kg* 45 minutes 4–6 hours Remifentanil is currently not recommended for sedation analgesia in children. * Number of drops = body weight/2.5. 8.2.1.4 Naloxone 8.2.1.2 Fentanyl and alfentanil Naloxone is a specific opioid antagonist that will reverse the Fentanyl and alfentanil are potent, short-acting opioids respiratory depressant, as well as analgesic, effects of opioids, with significant potential for respiratory and cardiac and should be readily available whenever opioids are used depression, particularly when used in combination with (Table XV). It should only be used in cases of severe respiratory other respiratory depressant drugs (Table XIII and XIV). depression or respiratory arrest, as reversal of the analgesic Practitioners administering these drugs intravenously should effects may cause a profound sympathetic response. As the be experienced sedationists with airway management skills. duration of action is short, respiratory depression may recur, Meticulous monitoring of respiratory and cardiovascular requiring additional doses. For this reason, monitoring should parameters throughout the procedure and recovery period is continue for at least two hours after administration of naloxone. imperative. Naloxone should be at hand. Once a response to the intravenous dose has been achieved, the additional total effective dose could be administered Fentanyl and alfentanil should not be used as sole analgesic intramuscularly. In an emergency, if intravenous access is not agents, but rather to augment the effects of simple analgesics. available, the initial doses may be given intramuscularly. When used in combination with other depressant drugs, such as midazolam, doses should be reduced and titrated to effect. Table XV: Dosing schedule of naloxone Slow titration of small boluses will decrease, but not eliminate, the possibility of adverse events. Dose Titration Maximum Duration of interval* dose action In patients at risk of upper airway obstruction, administration of fentanyl or alfentanil may precipitate this event. 1–2 µg/kg 2 minutes 1 mg/kg 45 minutes * Repeat dose until desired effect achieved, or maximum dose reached. Neonates may experience prolonged sedation and respiratory depression because of slower metabolism and excretion, and extreme caution should be exercised in this age group. 8.2.2 Nitrous oxide

Extreme care should be exercised in the post-procedural N2O is an anaesthetic agent with analgesic properties. It is period when the stimulus of the procedure has passed, but available in pure form or premixed in a 1:1 ratio with oxygen, the drug is still active and more likely to cause respiratory known as Entonox®. depression.

In older children who can hold a mask, N2O is an agent with Table XIII: Single agent dosing schedule of fentanyl a rapid onset and offset of action and an excellent safety profile. The recommended administered Route of Dose Onset of Time to Maximum Duration concentration is 50% (Table XVI). If a higher administration action peak dose of action concentration is administered, this must be classified effect as moderate sedation, with all the implications for Oral or 1 – 5 µg/ 15–30 30–45 5 µg/kg 1 hour* monitoring of the patient attached to this level of transmucosal kg minutes minutes sedation. For painful procedures, analgesia must be Intravenous 0.25 µg/ Immediate 3-8 2 µg/kg 30 supplemented with, for example, local anaesthesia. kg** minutes minutes* If other sedatives are used, respiratory depression must be anticipated. When used in combination with other drugs, doses should be decreased and titrated to effect * Dose-related ** Titrate to effect, repeating dose every three minutes until desired level of analgesia Although N2O is emetogenic, no clinically apparent achieved or maximum dose reached cases of aspiration have been reported.

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N2O is only recommended in ASA I and II patients. In those 8.2.4 Local anaesthetics with myocardial disease, N2O may cause a detectable degree of myocardial depression and, in patients with respiratory Local anaesthetics should be considered wherever possible, disease, it may alter the response to hypoxia. bearing in mind that additional sedation or anxiolysis might be necessary. They can be used topically or by infiltration.

N2O diffuses into air-filled cavities and should not be used in the following cases: EMLA® (Eutectic Mixture of Local Anaesthetics) requires at • Chest injuries with possible pneumothorax. least an hour for full effect. It can be used on intact or broken • Head injuries with possible pneumocranium. skin and penetrates to a depth of 3-12 mm. • Suspected bowel obstruction. Warming and alkalinising the solution of local anaesthetic may

N2O is best administered via a demand-valve system reduce the sting experienced on infiltration connected to a cylinder of Entonox®. The procedure should be fully explained to the child, who should be able to hold It must be noted that the local anaesthetics are membrane the mask with the demand valve without assistance. The depressants and, if given in excessive doses, may depress sensitive demand valve is activated by the child’s inspiration, the cardiovascular and respiratory systems. This is especially with the rate of delivery of gas determined by the strength of important in PSA for dentistry if a block does not take effect inspiration. and further doses of local anaesthetic are given.

In those children unable to operate a demand valve, a Note that toxicity is additive; if one drug is used in combination breathing circuit with continuous flow from an anaesthetic with another, the combined dose should not exceed the machine may be used. Scavenging should be available for maximum safe dose of either drug (Table XVIII). such cases. To avoid the delivery of a hypoxic mixture when ® delivering N2O, other than as Entonox , in-circuit gas analysis Table XVIII: Maximum safe doses of local anaesthetic drugs should be employed. If concentrations above 50% have been administered, supplemental oxygen should be administered Drug Dose with adrenaline Dose without for several minutes after N2O has been discontinued, to adrenaline counter the possibility of diffusion hypoxia. Lignocaine 7 mg/kg 3 mg/kg Table XVI: Dosing schedule of nitrous oxide Bupivacaine 2.5 mg/kg 2.5 mg/kg

Dose (concentration Onset of action Time to peak effect 9. Environment and clinical setting administered) 50 % 30–60 seconds 3 minutes Sedation should only be performed in an environment where the facilities, personnel and equipment to manage emergencies are immediately available. 8.2.3 Simple analgesics Where the procedure will not be performed in a standard Simple analgesics are analgesic drugs which have no sedative hospital operating theatre, the minimum necessary facilities effects. must include an operating surface that can be tilted and the equipment and disposables as listed (Table XIX). Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) are extremely useful, but must be allowed time All equipment should be checked regularly and stored in a to take effect before a procedure is performed (Table XVII). mobile cupboard. NSAIDs should be avoided in any child requiring fluid resuscitation, until good urine output is established. It is critical for a roving or mobile sedation practitioner to ensure, before commencing sedation, that all of this equipment Suppository formulations of these drugs do not consist of a is available. uniform distribution of the active ingredient. As a result, they cannot be divided to administer smaller doses. 10. Monitoring

Table XVII: Dosing schedule of simple analgesics Prior to the commencement of sedation, baseline vital signs should be recorded. It is recommended that observations be Drug Route of Dose Time to peak recorded on a sedation monitoring chart (Appendix 5a). administration effect Paracetamol Oral 20 mg/kg 100–120 minutes In simple or basic sedation, someone other than the operator must be responsible for monitoring the patient. Rectal 40 mg/kg 60–240 minutes Intravenous 15 mg/kg 50 – 60 minutes In advanced sedation, someone other than the operator must Ibuprofen Oral 10 mg/kg 120–240 minutes be responsible for the administration of sedation, monitoring Diclofenac Rectal 1–1.5 mg/kg 30–45 minutes of vital signs and, should complications of sedation arise, rescue of the patient. It is recommended that, in such cases, a Ketorolac Intravenous 0.5 mg/kg 60–120 minutes medical practitioner performs this role.

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Table XIX: Checklist of equipment required for paediatric PSA

Equipment to open and protect the airway Face masks Size 0, 1, 2, 3 and 4 Laryngoscope set Two handles with adult and paediatric blades, and spare bulbs and spare batteries Endotracheal tubes Uncuffed (sizes 2.5–5.5 mm) Cuffed (sizes 5.0–7.0 mm) Water-soluble lubricant/KY jelly 10 ml syringe Tape, or equivalent, to tie endotracheal tube in place Oropharyngeal airways Sizes 0-5 Nasopharyngeal airways Sizes 6 and 7 In smaller children, one can use an endotracheal tube cut to size in nasopharynx Equipment to confirm tracheal intubation Stethoscope

End-tidal CO2 monitoring Desirable, particularly for longer, complex cases and when using advanced sedation techniques Equipment for difficult intubation Introducers for endotracheal tubes/gum elastic bougie Adult and paediatric stylets Magill’s forceps Adult and paediatric Laryngeal masks Sizes 1.5–3 Equipment to deliver oxygen and ventilate patients Bag-valve ventilation devices with PEEP valve adaptor Oxygen reservoir with adult, paediatric and neonatal masks

Oxygen delivery devices Masks, nebulizer masks, nasal prongs (+ CO2 monitoring) and T-piece Oxygen supply The oxygen source must be reliable and able to provide at least 90% oxygen via a self-inflating positive pressure delivery system, at 15 l/minute for at least 60 minutes Oxygen and oxygen tubing With flow regulator and oxygen tubing for bag-valve device Equipment to diagnose and treat cardiac dysrhythmias ECG monitor defibrillator With conductive paste or pads, paddles, electrodes and razor Cardiac arrest board Equipment to gain intravascular access Tourniquets Alcohol skin wipes Sterile gauze pads Intravenous cannulae 18-24 gauge Needles and syringes 1-50 ml syringes Sharps container Paediatric intraosseous needles Tape Appropriate strapping and dressings for paediatric intravenous access Equipment for accurate infusion of drugs and fluids Infusion pumps Intravenous fluid administration during simple sedation Syringe drivers Drug administration during advanced sedation Intravenous administration sets Administration sets and buretrol Intravenous fluids Crystalloids and colloids Equipment for monitoring airway, breathing and circulation Stethoscope/praecordial stethoscope Pulse oximeter Adult and paediatric probes Non-invasive blood pressure monitoring device Including paediatric and adult cuffs Thermometer Including low-reading capability Blood glucose testing Capnograph Desirable but not compulsory; nasal prongs with capnography line Miscellaneous Drip stand, or equivalent suspension device Suction devices and suction catheters Including catheters for suctioning endotracheal tubes, and Yankauer-type suction nozzles Therapeutic heating source Desirable for long cases Universal precautions Including gloves Tilting operating surface or trolley Capable of Fowler’s and Trendelenberg positions Procedure lighting Adequate for intravenous access Medication stickers South African Resuscitation Council algorithms Basic Life Support (BLS), Advanced Life Support (ALS) for adults and children, anaphylaxis (www.resuscitationcouncil.co.za) management and choking Resuscitation documentation record

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Close and continuous observation of the child’s face and Table XX: Discharge scoring system chest wall motion is likely to aid in the early identification of problems, and must form the basis of all monitoring. This could Physical sign Clinical level Score be supplemented, but not be replaced, by monitoring devices. Level of Fully awake/alert/answers questions 2 Clinical monitoring should include assessment of level of consciousness consciousness (LOC), colour, breathing rate and pattern and Rousable to verbal command 1 signs of pain or anxiety (See Appendix 4). There are several No response 0 scales which can be used to measure LOC, for example, the Respiration Able to take deep breaths and cough 2 University of Michigan Sedation Scale (UMSS). adequately Shallow breathing with poor cough 1 For simple sedation, pulse oximetry must be utilised. For Apnoeic periods 0 advanced sedation, pulse oximetry, ECG and non-invasive blood pressure must be monitored and capnography is Oxygen > 96% on room air 2 saturation Requires oxygen to maintain saturations > recommended, particularly in situations where continuous 1 airway monitoring is problematic. If capnography is not 90% available, a praecordial stethoscope may be used. Saturation < 90% with oxygen 0 Movement Able to move all four extremities on 2 Monitoring of the airway, respiratory rate and pattern, heart command rate, oxygen saturation and LOC should continue in the Able to move two extremities on command 1 recovery area (Appendix 5b), until the discharge criteria are met (Appendix 5c and 5d). Not able to move extremities on command 0 Temperature 36–38 °C 2 11. Discharge 35.5–35.9 °C or 38.1–38.5 °C 1 < 35.5 °C or > 38.5 °C 0 Premature discharge has been identified as a major contributing factor to severe morbidity and mortality in several Pain Minimal discomfort or pain 2 post-sedation adverse event analyses. Significant pain 0

Preparation for discharge starts in the recovery area. The discharging the child home, the following criteria should be recovery area should be staffed by a health care professional, met: capable of basic life support, who is responsible for monitoring no more than two patients simultaneously. A • There are no surgical complications (e.g. bleeding after medical practitioner should assume overall responsibility for dental procedures). the patients in the recovery area, and should not leave the • The child is able to take fluids orally. premises until the discharge criteria are met. • There is no nausea or vomiting. • An analgesia management plan is in place. When long-acting drugs have been used, there will be a delay to discharge readiness and a risk of resedation. These children The discharge questionnaire (Table XXI, Appendix 5d) can aid will require prolonged stays in the recovery area. in determining if the patient is ready for discharge home.

Depending on the facility where the PSA has been Table XXI. Discharge questionnaire performed, discharge from the recovery area can be either to the ward and then home, or directly from the recovery Yes No area to home. Fully awake and aware. 11.1 Discharge criteria: from the recovery area to the ward Breathes comfortably and colour is normal. Can swallow and cough. A discharge scoring system (Table XX, Appendix 5c) is Can walk without feeling faint, or able to move recommended to establish readiness for discharge from the extremities. recovery area to the ward. The child should score at least Normothermic. 12 points prior to discharge. In addition, there should be no procedural or surgical complication (e.g. bleeding). Has minimal discomfort or pain. Not nauseated, or only minimal, on ambulation). A separate, simple evaluation aid may be the ability of the Operative site checked and bleeding controlled. child to keep his or her eyes open for 20 minutes after Able to take fluids orally. sedation in the recovery area, in a quiet environment. Once Post-sedation instructions given and explained to the child is able to fulfil this criterion, he or she is usually fit parent/guardian/responsible person, including analgesia to be discharged. management plan. Possible complications explained. 11.2 Discharge criteria: from the health care facility to home Prescription or medication given. Suitably accompanied by parent/guardian/responsible In addition to the criteria for discharge to the ward, prior to person.

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Children may only be discharged home into the care of a parent/guardian/responsible person, according to local parent, guardian or other responsible person. This parent/ and international requirements (Appendix 2). guardian/responsible person must be given clear instructions, and must have access to a telephone. The instructions to the • Pre- and post-sedation instructions. It is advisable to provide parent/guardian/responsible person should include: information (Appendix 3) to the parent/guardian/responsible person regarding the sedation process. This should include • Do not leave the child unattended at any time in a car the aims, objectives and possible side effects of sedation. seat. In a car, the child should be continuously watched to All information and instructions should be provided, see that there is no difficulty in breathing. In cases where both verbally in writing. In addition, the name, address the primary carer may be driving the car, it is strongly and a telephone number (including after hours) of the advised that a second adult is present to constantly parent/guardian/responsible person should be recorded. supervise the child. • Eating and drinking must be slowly initiated over the next 12.2 Documentation immediately before sedation few hours, and only if the child is completely awake and alert. The final points checked prior to commencing sedation • No play that requires coordination should be attempted should be documented. An evaluation of the child’s condition, for the next 12 hours (e.g. cycling, skating, swimming, including any changes that took place after the completion climbing). The child should rest quietly at home. of the medical history questionnaire should be written • Supervise all playing and/or bathing for the next 12 down. It is also important to record the details of the check hours. Do not leave the child alone at home. for appropriate equipment in the sedation suite. This • In case of vomiting, strange and unusual behaviour, or document may take the form of a pre-procedural checklist any other symptom or sign that does not seem normal (Appendix 8). for the child, seek immediate help or dial the provided telephone number. 12.3 Documentation during sedation • Give the medication as prescribed by the physician. The sedation monitoring chart is a time-based document that If the parent/guardian/responsible person does not understand includes the name, age and weight of the patient, as well as and agree to the above, the child is not ready for discharge. the route, time, and dose of administered drugs (Appendix 5a).

12. Documentation required during procedural sedation The chart must include information regarding the vital signs, and analgesia which should be monitored and recorded at least every 10 minutes. • Documentation before sedation: −− Medical history questionnaire. Before any sedative drug is administered, baseline −− Informed consent. documentation of all vital signs is necessary. −− Pre- and post-sedation instructions.

If capnography is utilised, the value of the end-tidal CO2 • Documentation immediately before sedation: concentration must be documented on the chart. −− Pre-procedural checklist, including equipment check. Adverse events and complications during sedation must be • Documentation during sedation: documented on the chart. Any action taken, and any escalation −− Sedation monitoring chart, including practical of care or requirement for hospitalisation, should be recorded. clinical monitoring recommendations. To assess the level of consciousness, a variety of sedation • Documentation after sedation: scoring systems are available. It is advisable to use the −− Post-sedation monitoring chart, with discharge simplest and most practical scoring system. The UMMS can scoring system. be recommended (Appendix 4). −− Discharge questionnaire. Any behavioural problems occurring during the sedation or It is important to remember that, unless it has been written recovery period should also be recorded on the form, and down, it never happened! reported to the parent/guardian/responsible person.

12.1 Documentation before sedation 12.4 Documentation after sedation

• Medical history questionnaire (Appendix 1). This should The vital signs must be monitored and recorded at least every be completed by the parent/guardian/responsible person 10 minutes, until full recovery has taken place (Appendix 5b). and evaluated by the sedation practitioner. Prior to the commencement of sedation, and as part of the patient Formal documentation of the patient’s clinical condition must assessment, possible changes in the patient’s condition be performed before discharge from the facility (Appendix 5c should be sought and a risk evaluation performed. and 5d).

• Informed consent. This document must show that Before the child is sent home, post-sedation instructions appropriate consent was obtained from, preferably, the for the care of the child must be given to the accompanying

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parent/guardian/responsible person. It should be stressed that 14. Procedure-specific recommendations the child must not be left alone for at least the next 12 hours. Whenever possible, PSA should consist of both pharmacological 13. Adverse events accompanying procedural sedation and non-pharmacological strategies. and analgesia Non-pharmacological strategies include psychological pre- Most procedures pose little risk to the patient. However, the paration, nutritive and non-nutritive sucking, distraction and administration of sedatives and analgesics may add to the basic physical measures, such as the application of ice or risk. Adverse events during PSA most commonly occur as a splinting or a combination of these. result of the drug-induced depression of respiratory function. Adverse events are more likely if a combination of drugs When providing procedure-specific recommendations, one (particularly three or more) is used. must take into account the interindividual variation in the reaction to drugs that are inherent in children. There is no Adverse events can also be related to poor patient rescue fixed dose for any sedative agent in children, only a maximum skills, inadequate monitoring, and poorly defined discharge dose. criteria. Drug selection should depend on the requirements for the Complications can be minimised by training practitioners in procedure: airway management, because the maintenance and protection of the airway is a crucial part of safe sedation practice. • Analgesia • Anxiolysis Adverse events and complications are more likely in non- • Sedation hospital-based settings that do not meet the minimum • Amnesia requirements for safe sedation practice. Attention to • Immobility environmental factors is essential for the safe practice of procedural sedation and is a basic requirement for ensuring a If a procedure is not painful, it is advised that agents such as satisfactory outcome. ketamine or the opioids not be used routinely.

Audits of the procedures, as well as all critical adverse events, 14.1 Psychological preparation of children for procedures should be performed at least annually. An example of an adverse event reporting form is included in Appendix 9. Preparing children and their families for procedures and medical events can significantly increase their confidence and Adverse events may arise because of: ability to cope with the experience.

• Factors related to drugs: Preparation should include all sensory information, a −− Drug interactions. description of the sequence of events, and the expected −− Drug overdose, including local anaesthetic toxicity. duration of the procedure. When preparing the child, let him −− Incorrect selection of drugs (e.g. opiates for painless or her smell, touch and feel the items that may be used, for procedures). example, smell the alcohol swab, touch the wet swab, and feel −− Prescription errors, particularly with oral how cool it is to the touch. formulations. −− Drug combinations. Talking to children is different from talking to adults. In order −− Unanticipated (pharmacogenetic) responses to drugs. to provide helpful information, the child’s developmental level, −− Unsupervised administration (e.g. by a parent at age, culture, and education should be taken into consideration. home). Young children have no sense of reason. “You will feel better −− Lack of knowledge of the pharmacokinetics and after this medicine has been given” is of no apparent benefit to pharmacodynamics of drugs. them; they will remain fearful. Medical terminology should be avoided, and extensive explanation to both child and parents • Factors related to skills: is usually necessary. −− Inadequate clinical evaluation, especially of the airway, and inappropriate patient selection. The use of pictures or actual equipment as aids is strongly −− Inadequate experience in paediatric sedation. recommended. Medical play has considerable benefit. This −− Inadequate problem recognition. is especially the case when the child is expected to undergo −− Inadequate support staff qualifications. ongoing or repeated treatment. −− Inability of the sedationist to rescue a patient from an unexpected or undesirable deep level of sedation. Looking down on, or talking over, a child should be avoided. −− Inadequate resuscitation skills. Children are much more receptive to information when one is at their level. • Factors related to the environment: −− Inadequate monitoring. The caregiver plays a vital role in the hospitalisation of young −− Inadequate equipment. children. He or she will have an understanding of the child’s needs and is best equipped to interpret the child’s behaviours • Premature discharge, and not following discharge criteria. and reactions. Frequent conversations with caregivers

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are crucial to success, and sufficient time should be made • Surgery of prolonged duration. available for asking and answering questions. • Fillings vs. extractions; children may misinterpret pressure as pain. By initially providing accurate and developmentally appropriate information, a family’s level of uncertainty can be reduced, The following are recommended PSA techniques for dental and their sense of control and involvement increased. This procedures: can lead to less emotional distress, and also result in the continuation of accurate information processing and the • A local anaesthetic must be administered for analgesia. development of positive coping strategies. The long-term Topical anaesthesia should be used before the local benefits of this to the child, the parents and the medical staff anaesthetic injection. should not be underestimated.

• A basic technique of < 50% N2O in oxygen is still one 14.2 Acute pain control and sedation for specific of the best in paediatric dentistry for minor procedures. procedures However, this cannot be used for all cases.

Chloral hydrate, midazolam and N2O in oxygen (usually less • Oral drugs (e.g. midazolam) can be used, but must than 50%) can be considered for painless procedures. always be administered on the premises where sedation will take place, never at home. The inhalational agent sevoflurane is being used, by those trained in anaesthesia, for painless procedures outside • Advanced techniques may be useful in children. the operating room (e.g. painless imaging procedures) in concentrations of less than 0.3%. Environmental con- Extractions may be a challenge, as children cannot distinguish tamination will, however, occur. between pressure and pain. The correct timing of drug administration is, therefore, critical. Anaesthetic doses of Effective regional analgesia is extremely important in drugs should not be used. procedural sedation and analgesia. Drugs and combinations of drugs that can be administered for 14.2.1 Dental procedures fillings and extractions:

During dental procedures, the dentist and the sedationist • Antisialogogues can be administered to reduce share the airway. It is useful, therefore, to have two suction secretions, although this is usually not a major problem, catheters to remove fluids. as most procedures are performed in the head-down position. The sedation practitioner must remember that there are factors that may increase risk and factors that will increase • Midazolam should not be administered at a dose of risk of adverse events during PSA in dentistry. Not only the > 1 mg intravenously, particularly if other respiratory drugs administered can increase the risks associated with depressant drugs are used. In children, the dose of PSA, but also human factors, including lack of knowledge and midazolam should always be titrated. skills and poor judgement. • Ketamine, when administered slowly and titrated, Factors that may increase the risk of an adverse event include: is a relatively safe intravenous drug. The timing of administration is crucial. Ketamine should be given • Anxiety before the injection of the local anaesthetic. • Pain • Movement Local experience suggests: −− Slow intravenous administration of 0.2–0.3 mg/kg Factors that will increase the risk of an adverse event include: of ketamine one minute before the local anaesthetic is injected. • Desaturation −− This can be repeated after 10 minutes if • Airway obstruction necessary, but it is not advised to give more • Laryngospasm than 1 mg/kg/hour. As the dissociative sedation • Bronchospasm produced by ketamine lasts about 10 minutes, it • The operator (dentist) may be necessary to repeat the dose of ketamine to maintain sedation. The problems that could be encountered during sedation for −− When other sedative drugs are administered with dental procedures include: ketamine, it is advised that the dose of ketamine not exceed 1 mg/kg/hour. • Flexion of the neck (placing a cushion or towel behind the shoulders will prevent this). • The opiate of choice is alfentanil, because of its short • Secretions. duration of action. This is particularly important when • Water from the drill. multiple injections have been given and substantial • Depression of the chin, especially when working on the pressure must be exerted to remove teeth. lower jaw.

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Local experience suggests: • In difficult cases, general anaesthesia may be preferable. −− Dilute 500 µg of alfentanil in a 20 ml syringe, so that the concentration of alfentanil is 25 µg/ 14.2.2.1.4 Ocular examination for retinopathy of prematurity ml. The recommended dose for alfentanil is up to 1 µg/kg. For a 20 kg child, for example, this will be • Local anaesthetic eye drops should be administered. approximately 20 µg. A safe practice is to give half of • A pacifier should be offered. the dose and monitor the effect on respiration before • Sucrose may contribute to a reduction in the response administering the rest. to pain. −− Alfentanil should be administered 1.5 minutes before the pain or pressure stimulus is expected. 14.2.2.1.5 Lumbar puncture

• Propofol should only be administered by highly • Topical local anaesthesia is effective in reducing lumbar experienced sedation practitioners. This drug is useful puncture (LP) pain. for longer operations. • Topical local anaesthesia does not decrease success rates. • Consider adding simple analgesics. When combinations of drugs are used, the doses of the • Avoid hyperflexion of the neck for the procedure, as this individual drugs should be reduced. adds to discomfort.

14.2.2 Medical procedures 14.2.2.1.6 Urine sampling

14.2.2.1 Procedural pain in the neonate • Transurethral catheterisation, with local anaesthetic gel, is preferred to suprapubic aspiration after infiltration with If it is feasible, breastfeeding mothers should be en- a topical local anaesthetic, as the former method is less couraged to nurse the baby during the procedure. Non- painful. nutritive sucking and/or the use of sucrose or other sweet solutions (25% dextrose on a pacifier) can be used for brief 14.2.2.2 Procedural pain in older children procedures. The children and their parents may benefit from psychological 14.2.2.1.1 Blood sampling and intravenous cannulation preparation prior to painful procedures. Explaining the procedure may be crucial to success. • Sucrose or some other sweet solution should be used. • Topical local anaesthetics may be used for venepuncture Pain management for procedures should, where possible, pain. include both pharmacological and non-pharmacological • Visual or tactile stimulation is also useful. strategies.

14.2.2.1.2 Heel prick (lancing) Entonox® should be considered for painful procedures in children who are able to cooperate with self-administration. • Avoid puncturing the same site each time, as bruising aggravates pain. Sedation or general anaesthesia should be considered for • Warm the heel. invasive, multiple and repeated procedures. • Avoid the apex of the heel, where there is less subcutaneous tissue. 14.2.2.2.1 Blood sampling and intravenous cannulation • Give oral sucrose. • Allow breastfeeding during the procedure. • Topical local anaesthetics may be used for venepuncture • When several blood investigations are required, pain. venepuncture (which is less painful) is preferred to a heel • Psychological strategies, e.g. distraction or hypnosis,

prick. should be used to reduce pain and anxiety. N2O is • Topical local anaesthetics alone are insufficient analgesia effective for pain reduction in venous cannulation. for heel prick pain. • Morphine alone is insufficient analgesia for heel prick 14.2.2.2.2 Lumbar puncture pain. • Sensory stimulation, including tactile stimulation (holding • Behavioural, non-pharmacological techniques of pain or stroking), can be employed alone or combined with management should be used to reduce LP pain. It is sucrose, where feasible, as this may further reduce the essential to explain the procedure to older children. pain response. • Topical local anaesthesia is effective in reducing LP pain. • Topical local anaesthesia does not decrease success 14.2.2.1.3 Percutaneous central venous catheter insertion rates. • Inhaled Entonox® should be offered to children willing • Topical local anaesthesia alone is insufficient to abolish and able to cooperate. the pain associated with peripherally inserted central • Anxiolytic medication is an advantage (e.g. midazolam or catheter (PICC). clonidine, orally). • In ventilated infants, local anaesthesia plus morphine is • Avoid hyperflexion of the neck for the procedure, as this recommended. adds to discomfort.

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Local experience suggests: 14.2.3.2 Circumcision of the older child

• Psychological preparation is important. • A dorsal penile nerve block provides similar analgesia to • Place an EMLA® patch on the intended site for LP, and caudal block, and is more effective than application of leave for an hour before the procedure. EMLA®. • Consider the use of tilidine, clonidine or paracetamol. • Toxic effects of EMLA® are seen with repeated doses in • Infiltrate with local anaesthetic, down to spine, using a the postoperative period. 26G needle, with 1% or 2% lignocaine. • Subcutaneous ring block of the penis is less effective • Perform the LP without excessive flexion of the neck. than dorsal penile nerve block and has a higher failure rate than caudal analgesia, but potentially fewer 14.2.2.2.3 Urine sampling complications.

• Prior to bladder catheterisation, a lubricant local 14.2.3.3 Bone marrow trephine biopsy anaesthertic should be instilled in the urethral mucosa via a purpose-made applicator (e.g Cathigel®). • General anaesthesia is the only completely pain-free • Psychological preparation and behavioural in- method of sedating these patients. terventions should be used during bladder • Sedative and analgesic options include midazolam, catheterisation and invasive investigations of the ketamine, local anaesthetics (topical and infiltration), and urinary tract. Entonox®. Critical adverse events are more likely when multiple medications are administered. 14.2.2.2.4 Insertion of a nasogastric tube 14.2.3.4 Chest drain insertion and removal • Prior to placement, to reduce the pain and discomfort of nasogastic tube (NGT) insertion, apply a topical local • For chest drain insertion, consider general anaesthesia anaesthetic, such as lignocaine-containing lubricant gel or sedation, combined with subcutaneous infiltration or atomised/nebulised 4–10% lignocaine. of alkalinised lignocaine. Selection of the appropriate • If using 10% lignocaine, beware of the toxic dose. drain type may reduce pain by facilitating easy insertion. Supportive strapping of the drainage tubing reduces Local experience suggests: traction and pain at the insertion site. • For chest drain removal, consider a combination of two • Insert two drops of oxymetazoline (0.025%) in each or more strategies known to be effective for painful nostril. procedures, such as psychological interventions, sucrose

• Insert a small amount of amethocaine gel in the or a pacifier (in neonates), opioids, 2N O (as long as there designated nostril. are no contraindications for its use), and NSAIDs. • Wait for five minutes. • Intercostal nerve block is an alternative technique. • Gently move the head of the child into a neutral position. • Insert the NGT, in a medioposterior direction, into the 14.2.3.5 Burns: changing dressings posterior pharynx • Wait for the child to swallow, then give a little water orally • Non-pharmacological options, such as distraction, to assist whilst advancing the NGT. relaxation, and massage, should be considered as part • Secure the NGT so that it lies flat on the upper lip or of pain management for dressing changes in burned cheek, avoiding traction on the nostril and lateral children. pressure on the ear lobe. • Positioning the children in a way that provides comfort, and where they are unable to see what is happening, is 14.2.3 Surgical procedures important. • Potent opioid analgesia, given by oral, transmucosal 14.2.3.1 Neonatal circumcision or nasal routes (according to patient preference and availability of suitable preparations), should be considered • Consider the use of general anaesthesia, local anaesthesia for dressing changes. Ketamine, orally or intravenously, and multimodal analgesia, as well as sucrose or breast should be considered as an adjunct or alone. milk. • Only practitioners trained in airway and resuscitation • Topical local anaesthesia does not provide adequate management should administer potent intravenous analgesia in the awake neonate. Topical local anaesthetic agents. cream (EMLA®) only partially attenuates the pain response to circumcision in awake neonates, so more Local experience suggests the following drug combinations: effective analgesic techniques, such as dorsal penile nerve block, are recommended. • Paracetamol + ibuprofen + clonidine (oral) + tilidine • Toxic effects of EMLA® are seen with repeated doses in (sublingual). the postoperative period. • Paracetamol + ibuprofen + codeine (oral) + tilidine • General anaesthesia with local anaesthetic techniques (sublingual). will provide the best operative conditions. • Paracetamol + ketamine ± midazolam (oral). • Paracetamol + ibuprofen + midazolam (oral) + tilidine (sublingual).

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• Entonox® (inhaled) ± adjuncts. most cases, general anesthesia is preferred, but this is not • Midazolam + paracetamol + codeine (oral). always feasible. • Midazolam + paracetamol + morphine (oral). • Midazolam + ketamine + atropine (intravenous); only In the acute trauma patient, the oral absorption of drugs is experienced practitioners. unreliable, and intravenous routes of administration may be • Morphine + paracetamol (Perfalgan®) ± midazolam preferable. (intravenous); only experienced practitioners. • General anaesthesia; only experienced practitioners with Local experience suggests the following drug combinations: anaesthetic training. • Tilidine or ketamine are valuable rescue options. • General anaesthesia + intravenous paracetamol. • Fentanyl, alfentanil, or remifentanil are very good • Ketofol + intravenous paracetamol. short-acting analgesics, but are associated with a high • Ketamine + intravenous paracetamol. incidence of cardiorespiratory events, and should not be • Morphine + intravenous paracetamol. used by inexperienced practitioners. • Tilidine + intravenous paracetamol ± ketamine. • Clonidine is an excellent alternative to midazolam • Nerve block in conjunction with any of above; discuss for anxiolysis, and has the added advantages of this with the orthopaedic surgeon. good analgesia, some sedation and no respiratory depression. If the intravenous preparation of paracetamol (Perfalgan®) is • Chloral hydrate is a sedative and has no analgesic action. not available and the oral route is unsuitable, the rectal route of administration (suppositories) should be considered. 14.2.4 Procedures in the trauma and emergency unit 14.2.5 Procedures in the radiology suite 14.2.4.1 Laceration repairs 14.2.5.1 Magnetic resonance imaging, computed tomography For extensive wounds, or for children who are very anxious, and ultrasound general anaesthesia should be considered. Common investigations include magnetic resonance imaging For repair of simple, low-tension lacerations, tissue adhesives (MRI), computed tomography (CT), and ultrasound. For these should be considered, as they are less painful, quick to use procedures to be successful, the child must remain immobile and have a similar cosmetic outcome to sutures or adhesive for varying lengths of time. These are not painful procedures, skin closures. and a sedative agent is generally sufficient.

If sutures are needed, topical anaesthetic preparations (e.g. Non-pharmacological tactics should be employed whenever lignocaine–adrenaline–tetracaine (LAT) gel, if available) can possible, either alone or in combination with sedative agents. be used in preference to injected lignocaine, as they are less A thorough explanation of the procedure and the presence of painful to apply and are equianalgesic. These preparations are a parent in the room will often be sufficient for a successful safe to apply to broken skin, but should not be injected. It is investigation. The application of pictures to the inside of the not necessary to use a preparation containing cocaine. MRI or CT scanning tube and earphones with music or story- telling can also be effective. The noise of the MRI scanner To reduce pain on injection, alkalinisation of injected lignocaine is disturbing to most children, so the use of earphones or with sodium bicarbonate should be considered. earplugs will be necessary.

If injected lignocaine is used, pre-treatment of the wound with Pre-procedural evaluation is crucial. These children may a topical anaesthetic preparation, e.g. LAT gel, reduces the have comorbidities and this, coupled with the fact that pain of subsequent injection. there will be poor access to the patient whilst in the actual scanner, makes careful assessment and selection essential. The hair apposition technique (HAT) should be considered If any concerns arise as a result, a general anaesthetic for scalp lacerations. It is less painful than suturing, does not should be considered. require shaving, and produces a similar outcome. There is controversy regarding suitable PSA techniques for

Inhaled 50% N2O reduces pain and anxiety during laceration these procedures, as monitoring of and access to the patients repair. are suboptimal during the procedures.

14.2.4.2 Fracture manipulation Children under four months of age should be scanned while asleep after a feed, and with no sedation given. When sedation Immobilisation of a fractured limb is painful, and analgesia is required, chloral hydrate is the most common agent used. prior to this is necessary. In this setting, particularly if an There should be a low threshold for general anaesthesia in intravenous line is not yet established, sublingual tilidine is this age group. an excellent agent. Painless imaging, lasting less than 60 minutes in children For manipulation of a fracture, an assessment of the patient’s aged four months to five years, can be performed after airway and haemodynamic condition, as well as fasting status, administration of a low-potency oral sedative agent. Sedation will determine the technique used and the choice of drugs. For failure is often due to the administration of an inadequate

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amount of drug. The administration of drugs by a sedationist anaesthesia provides the safest and most efficient conditions in the radiology suite will provide more reliable and safer for both MRI and CT scanning. sedation. A quiet area should be chosen to encourage sleep. Positioning of the child should be done in such a way as to This is an uncomfortable environment, often with high-risk ensure an open airway. patients, and sedation or anaesthesia should not be initiated without careful planning. Depending upon the staff, facilities and monitoring equipment, each radiology unit should have its own set of Imaging for CT scanning is usually very quick and painless, but guidelines. many of these children have the potential for upper or lower airway obstruction, and good pre-procedural assessment is Long-acting drugs should not be used if the child is to return crucial to avoid an adverse event. Sedation principles are to an environment where monitoring is not available. the same as for MRI scanning. Many children are able to lie still for the short time required without any sedation, with a In more difficult children, and to avoid failed sedation, general thorough explanation of what to expect often being sufficient. anaesthesia may be the preferred option. In most cases, single-agent oral sedation is adequate. In those who require deep sedation, propofol or ketamine, because of Oral sedation options include chloral hydrate, trimeprazine, the short duration of action, are good options. However, these midazolam (higher incidence of movement), droperidol and drugs should only be administered by an appropriately trained clonidine. medical practitioner.

Administration of medication with a syringe is often more 14.2.5.2 Painful radiological procedures successful than if a spoon is used. The bitter taste of some agents may need to be disguised in a pleasant-tasting 14.2.5.2.1 Intussusception reduction fluid. There is worldwide controversy about this procedure, and Local anaesthetic cream should be applied to facilitate whether or not sedation should be administered. The problems painless drip insertion. relate to inadequate resuscitation prior to the reduction, the cause of the commonly associated haemodynamic collapse Local experience suggests: (whether procedure- or sedation-related), and the need to maintain abdominal tone while the procedure is being performed. • Chloral hydrate: −− Initial dose: Intussusception reduction requires very good analgesia with -- Three to six months of age: 25 mg/kg/dose. minimal sedation. Intravenous ketamine 1mg/kg provides -- Six months to one year: 50 mg/kg/dose. consistently good conditions for the procedure. Salivation is -- Older than one year: 75 mg/kg/dose. avoided with intravenous glycopyrrolate 10 µg/kg/dose or -- “Top-up” dose: administer half of the initial atropine 20 µg/kg/dose, administered concurrently with the dose, once only. If this is still inadequate, this ketamine. The addition of midazolam may be necessary, but the can be considered a failed sedation and the child incidence of side effects is greater. Intravenous paracetamol is should be scanned under general anaesthesia. recommended. Appropriate monitoring is important. • Midazolam alone: high likelihood of movement and sedation failure. 14.2.5.2.2 Cardiac catheterisation • Trimeprazine 2 mg/kg/dose and droperidol 0.1 mg/kg/ dose. Although this is not recommended in the literature, In children, cardiac catheterisation is best performed under local experience suggests it is comparable with chloral general anaesthetic. This allows for the control of ventilation hydrate for sedation. Both have a long onset and duration and good monitoring of the cardiovascular system, so that of action, which may delay discharge home. the results of the investigation are optimal. Heavy sedation • Pentobarbital is widely discussed in the literature, but not with three or more agents may impact on physiological

commonly used in South Africa. parameters such as oxygenation and end-tidal CO2 which, in • Clonidine. turn, will alter haemodynamic variables. Decisions about the further management of these patients may, as a result, be The use of intravenous or inhalational agents requires the adversely affected. The infiltration of a local anaesthetic at the attendance of an anaesthesiologist or a highly experienced catheter needle puncture site, prior to insertion, is advisable. sedation practitioner. Propofol, ketamine, dexmedetomidine Paracetamol is recommended. and the inhalational agents are examples. Dexmedetomidine is increasingly being used for sedation during MRI scanning Other painful investigations or therapeutic procedures in children, but only by those highly experienced in paediatric (e.g. nephrostomy insertion, large cavity abscess drainage, sedation, and with anaesthetic training. angiography and vascular injections with bleomycin) are best performed under general anaesthesia. MRI-compatible anaesthetic and monitoring equipment

(oxygen saturation, end-tidal CO2, blood pressure and ECG) 15. Setting up a sedation service is necessary. It is recommended that any facility providing MRI investigations for children should have this equipment When a sedation unit, facility or surgery is established, the available and in working order. In many cases, general following aspects deserve close attention in order to allow

S Afr J Anaesthesiol Analg S19 2010;16(5)(Supplement 1) Guidelines for procedural sedation and analgesia in children: 2010 Guidelines for procedural sedation and analgesia in children: 2010 Guidelines for procedural sedation and analgesia in children: 2010 Guidelines for procedural sedation and analgesia in children: 2010 Guidelines for procedural sedation and analgesia in children: 2010 Guidelines for procedural sedation and analgesia in children: 2010

for the safe provision of sedation services, regardless of the the sedation practitioner. Continuing professional development sedation techniques employed: is important to maintain the link between the SASA guidelines on PSA and standards of practice at the facility. It is crucial to • Environment, patient selection and patient assessment. regularly update of knowledge and skills. • Training requirements. • Sedation practitioner: experience. 15.4 Sedation practitioner: ability to rescue • Sedation practitioner: ability to rescue. • Record keeping. Patients may inadvertently progress to deeper levels of sedation. A sedation practitioner must be able to rescue a 15.1 Environment, patient selection and patient assessment patient from an unintended deeper level of sedation.

The sedation unit/facility/surgery, outside the operating 15.5 Record keeping theatre, must comply with all contemporary standards for safe patient care. Only patients classified as ASA I or II should All facilities providing sedation services must keep a register be sedated outside the operating theatre. It must be noted of procedures performed, with the sedation technique that certain patients (e.g. the obese), who may be classified documented. as ASA I or II according to clinical status, should actually be reclassified as at least ASA III and, as such, should be managed as higher risk patients. If sedation is planned for a procedure outside the operating room, such patients must be sedated by a highly experienced practitioner.

Patient selection and assessment must be done, before the procedure, by trained health care professionals. The results of these examinations should be documented in the patient record. A focused airway examination is mandatory for anyone who plans paediatric sedation.

Drugs and equipment must be appropriate, not only for the specific sedation technique used, but also for the treatment of adverse events and complications.

Documentation and institutional protocols, including written informed consent, monitoring charts and written instructions for the care of the patient on discharge, must comply with the SASA recommendations on PSA for children.

15.2 Training requirements

Thorough training is the foundation of safe sedation practice. Anaesthetic agents should be administered by health care professionals with anaesthetic training.

Every sedation practitioner must comply with the recommendations in the SASA guidelines and contemporary standards of training. Evidence of training in specific sedation techniques is highly recommended.

Core sedation training, including on the pharmacology of drugs, applied physiology and anatomy, patient monitoring, focused airway examination and rescue techniques, should be undertaken by each sedation practitioner. Evidence of in-house training and Paediatric Advanced Life Support (APLS, PALS) certification, if the sedation practitioner is administering moderate or deep sedation and analgesia, is highly recommended.

Sedation practitioners should be encouraged to seek training in simple and advanced sedation techniques.

15.3 Sedation practitioner: experience

The integrity of the sedation facility, and the effective selection and assessment of patients, is dependent on the experience of

S Afr J Anaesthesiol Analg S20 2010;16(5)(Supplement 1) Appendix 1: Medical history questionnaire

Medical history questionnaire

Name Sex Age Height Weight

Does your child suffer from, or is there a history of, the following? Tick either “yes” or “no” and, if any answer is “yes”, provide a detailed explanation.

YES NO 1. Cardiovascular disease High blood pressure Heart failure Heart valve lesion, rheumatic fever, or congenital heart disease Dysrhythmia, or fainting spells Shortness of breath when feeding, lying down, or walking on a level surface If any answer is “yes”, please provide a detailed explanation:

2. Respiratory disease Do either of the parents smoke? History of snoring Breathing difficulties Lung disease, e.g. asthma, tuberculosis If any answer is “yes”, please provide a detailed explanation:

3. Central nervous system disorders Epilepsy, or fits (convulsions) Behavioural problems, attention deficit disorder, or developmental delay If any answer is “yes”, please provide a detailed explanation:

4. Blood disorders Anaemia, sickle cell disorder, or thalassaemia Abnormal bleeding associated with previous dental extractions, surgery or trauma, or does the child bruise easily? If any answer is “yes”, please provide a detailed explanation:

5. Endocrine disorders Diabetes mellitus If the answer is “yes”, please give details of medication and degree of control of blood sugar:

6. Liver disease Hepatitis, or jaundice Other liver disease If any answer is “yes”, please provide a detailed explanation:

7. Kidney disease Renal disease or disorders, or renal failure If the answer is “yes”, please provide a detailed explanation:

8. Musculoskeletal disorders Muscle disorders, e.g. myopathy, dystrophy or progressive weakness Orthopaedic problems If the answer is “yes”, please provide a detailed explanation:

S Afr J Anaesthesiol Analg S21 2010;16(5)(Supplement 1) Appendix 1: Consent to Procedural Sedation and Analgesia (PSA) for Medical/Dental Procedures

YES NO 9. Infectious diseases If the answer is “yes”, please provide a detailed explanation:

10. Stomach problems Reflux, or regurgitation If the answer is “yes”, please provide a detailed explanation:

11. Previous admission to hospital If the answer is “yes”, please provide a detailed explanation:

12. Previous operations If the answer is “yes”, please provide a detailed explanation:

13. Previous adverse or unpleasant reaction to anaesthesia If the answer is “yes”, please provide a detailed explanation:

14. Previous problems with sedation If the answer is “yes”, please provide a detailed explanation:

15. History of allergy in general, or allergic reactions to medications If the answer is “yes”, please provide a detailed explanation:

16. History of taking medication or drugs, including herbal remedies and recreational drugs If the answer is “yes”, please provide a detailed explanation:

17. History of hereditary disease in the child’s family, e.g. porphyria, or malignant hyperthermia If the answer is “yes”, please provide a detailed explanation:

18. Is there anything you would like to discuss, but would prefer not to write down? If the answer is “yes”, please contact your sedationist and discuss this with him/her before the date of your procedure

………………………….…………….……………… ………………………….…………….……………… Signature (Patient/Parent/Guardian) Date

………………………….…………….……………… ………………………….…………….……………… Signature (Patient, if possible) Date

S Afr J Anaesthesiol Analg S22 2010;16(5)(Supplement 1) Appendix 2: Consent to sedation and analgesia for medical/dental procedures

Consent to sedation and analgesia for medical/dental procedures

I have been fully informed and I declare the following:

1. I understand the nature of procedural sedation and analgesia, the purpose of the procedure, and the risks involved. I understand that no guarantee can be given with regard to the results obtained.

Procedural sedation and analgesia entails the administration of sedative and/or analgesic drugs to induce a reduced level of consciousness to such an extent that normal protective airway reflexes and spontaneous respiration are maintained, and cardiovascular function is unaffected. Procedural sedation and analgesia, together with regional/local anaesthesia, will put my child in a relaxed state to make minor surgery possible. I understand that it is not a general anaesthetic and that my child will not be unconscious, as he/she may have to respond to commands from the surgeon and/or the sedationist.

2. Unforeseen adverse events may arise during/after sedation that may require additional or different medications or treatment. I authorise the sedationist to treat such adverse events according to his/her professional judgement:

3. Possible adverse events include unintended loss of consciousness, shivering, drowsiness, dizziness, headaches, and nausea and vomiting.

4. I give consent to the administration of such sedative and/or analgesic drugs, to my child, as may be considered necessary or advisable by the practitioner responsible for this service. This may include rectal medications/analgesia.

5. I have had the opportunity to ask questions and I have been given the opportunity to choose alternative methods of treatment to my satisfaction.

6. I confirm that I have received written/oral instructions regarding the sedation, which I understand. I will abide by the pre- and postoperative instructions. I have completed a medical history questionnaire for my child and have declared all drugs that he/ she has taken during the last 6 months.

7. If applicable, I accept full and complete responsibility for actual and potential costs associated with procedural sedation and analgesia, and I accept full responsibility for the costs that have been explained to me. I agree to comply with the terms and conditions of payment.

I, ……………………………………………………………………………………………………… (patient/parent/guardian), of address

………………………………………………………………………………………………… hereby authorise the following procedure/s

………………………………………………………………………………………………………………………………………………….. to be performed on (name of patient) …………………………………………………………....…………………… utilising procedural sedation analgesia/local anaesthesia techniques under direction of Dr ………………………..……….…………………………………

Patient/parent/guardian signature …………………………………………..………………………………….…………………………

Witnesses: 1. ………………………….…………….……………… 2. …….…….……………………………………………

Practitioner’s declaration: I have explained the procedure of PSA, risks, alternatives and expectations to the patient/parent/guardian, and believe that he/she has been adequately informed and has consented.

………………………….…………….……………… ………………………….…………….……………… Practitioner’s signature Date

S Afr J Anaesthesiol Analg S23 2010;16(5)(Supplement 1) Appendix 2: Consent to sedation and analgesia for medical/dental procedures Appendix 3: Pre- and post-sedation instructions

Pre- and post-sedation instructions

Please read the instructions carefully, and then fill in your details and fax to:………………………….…………….………………

Dear Patient/Parent/Guardian,

Your child needs to undergo a procedure/operation, and your doctor/dentist has chosen to do this under sedation. Please read the following information and instructions carefully. If anything is unclear, please contact your doctor/dentist:

Name of doctor/dentist: ………………………...... ….…………….………………

Telephone/cellphone number: ………………………….…………….………………

Pre-sedation instructions

- If your child suffers from any medical condition or takes any acute or chronic medicine, you will need to inform your doctor/dentist before the procedure/operation. A medical history questionnaire has been included; please complete this and return by fax (if possible) at least 48 hours before the procedure/operation. This is an important document, as it will help us to decide whether your child qualifies for the sedation that will have to be given for the procedure/operation. - If your child is sick or unwell in any sense, please call your doctor/dentist so that he/she can decide whether it is necessary to postpone the treatment. - Please ensure your child is dressed in comfortable clothes, with loose-fitting sleeves. - Please ensure your child does not eat anything for at least 6 hours before the procedure/operation. Breast milk may be taken up to 4 hours before, and water may be taken up to 2 hours before. - If your child takes chronic medication, please do give it on the day of the procedure/operation, after discussing this with the doctor/dentist. - Please ensure that you and your child arrive in good time for the appointment, at least 30 minutes beforehand. In some cases, your doctor/dentist may feel that your child will benefit from premedication to reduce his/her anxiety and make him/ her feel relaxed. If this is the case, the doctor/dentist may request that you come earlier for your appointment, so that your child may be given the premedication. - Please ensure that your child had emptied his/her bladder before the procedure/operation. - An escort may remain with the child until the sedation is underway and the procedure/operation is about to start. The escort will then be requested to leave the procedure/operation room. - It may be necessary to put a drip/needle in a vein in your child’s hand, arm or foot. Local anaesthetic ointment is available to apply beforehand. The doctor/dentist will discuss this with you and your child.

Post-sedation instructions (aftercare of the patient)

- A responsible adult must take the child home after the sedation. The child must remain in the company of this responsible adult for the remainder of the day. Sedation will not be given if the child arrives without an escort. - Once at home, your child must rest quietly. Interfere as little as possible with the child’s activities. - Your child may not engage in activity or play with equipment that requires alertness or coordination (e.g. swimming, cycling) for at least 12 hours following the procedure/operation. You should also keep your child away from potentially dangerous areas, like the kitchen, bath and pools of water. - If your child is taking any regular medication, ask the doctor/dentist when you should give him/her the next dose after the sedation. - The sedation may produce amnesia (memory loss). This is temporary, sometimes lasting for a few hours. After a dental procedure, be careful that your child does not bite his/her numb lip, as he/she will not be able to feel if it is painful. - About 20% of children complain that they see double, or cannot see, after sedation. This is a temporary drug effect, sometimes lasting for up to 6 hours. - Some children are aggressive after sedation. This may be a drug effect. Ensure that the child is not left alone. Contact the doctor/dentist if you are worried about this. - Introduce food and fluids slowly after sedation, as the child may feel nauseous and may vomit. - Your child should not experience nausea or vomiting after sedation. If your child vomits more than once, please contact

S Afr J Anaesthesiol Analg S24 2010;16(5)(Supplement 1) Appendix 3: Pre- and post-sedation instructions Appendix 3: Pre- and post-sedation instructions

your doctor/dentist. - Do not let the child eat or drink if he/she is nauseous. The child may have clear fluids after being instructed to do so by the doctor/dentist. If your child feels fine after having clear fluids, you may then progress to solids.

I, ………………………….…………….………………, the undersigned, have read and understood these pre- and post-sedation instructions, and agree to contact the doctor/dentist if there is anything more that is not clear to me.

………………………….…………….……………… ………………………….…………….……………… Signature (Patient/Parent/Guardian) Date

We do not anticipate that your child will have any adverse events or complications. Should you become concerned about anything, please contact the following, at these numbers:

Hospital casualty department: ………………………….……...……………

Ambulance: ………………………….…...... ………….………………

Dr ………………...... ………….…………….………………

Telephone: ……………...... …………….…………….………………

Cellphone:…...... ……………………….…………….………………

S Afr J Anaesthesiol Analg S25 2010;16(5)(Supplement 1) Appendix 3: Pre- and post-sedation instructions Appendix 4: Clinical monitoring for paediatric sedation

Clinical monitoring for paediatric sedation

The clinical observation of level of consciousness, breathing, colour and behaviour or body language forms the basis of the monitoring of a sedated patient. It is to be supplemented by monitoring devices, as detailed in the guidelines.

Level of consciousness

Communication with the patient is of key importance.

Check for response to simple commands, e.g. by saying “Open your eyes”. Most children over one year of age should be able to follow this instruction. If there is no reaction to this request, check the patient for a response to light touch, e.g. eye opening. A lack of response to both of these instructions indicates a deep level of sedation. Watch for signs of increasing depth of sedation, e.g. the mouth falling open.

Breathing

Look at the colour of the skin and mucous membranes of the patient. This is best seen in the face. The baseline colour should be pink, with any variation on this, tending towards blue, indicating hypoxia.

Look at the breathing pattern, paying attention to the movement of the chest and abdomen. In the sedated patient, breathing should be rhythmic. “Sucking in” of the abdomen with chest expansion suggests partial or complete airway obstruction, and is known as “paradoxical respiration”.

Listen to the movement of air from the patient’s mouth and/or nose. A partially obstructed airway will result in noisy inspiration and/ or expiration. This may sound like snoring or wheezing.

The likelihood of airway obstruction increases as the level of sedation deepens. This may be due to relaxation of the pharyngeal musculature or to the presence of obstructive tissue, such as adenoids or tonsils. Partial airway obstruction that is left untreated may result in hypoxia, and may progress to complete airway obstruction.

In the case of complete airway obstruction, no breathing sounds will be heard and paradoxical breathing will be present.

Behaviour

Confusion, restlessness and agitation may be signs of hypoxia, hypoglycaemia or oversedation. These possibilities should be considered before administering further sedation.

Watch and listen for signs of pain (screaming, groaning, withdrawing) and anxiety (tachycardia, sweating, voicing anxiety).

In the older, cooperative child, a sign (e.g. hand squeezing or thumbs up or down) may be discussed before sedation is initiated. This can then be used by the child to communicate well-being or discomfort to the observer.

University of Michigan Sedation Scale (UMMS)

0 = awake and alert

1 = minimally sedated Tired, sleepy, appropriate response to verbal conversation and/or sound

2 = moderately sedated Somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command

3 = deeply sedated Deep sleep, arousable only with significant physical stimulation

4 = unarousable

S Afr J Anaesthesiol Analg S26 2010;16(5)(Supplement 1) Sedation Monitoring Chart 5a: Appendix

ASA 1 2 3 4 5 E Date Time in Sedation monitoring chart Sedation Patient name Age Weight Time out Monitors Patient ID Heath Facility Sticker Premedication: Time:

ECG SpO2 Date of birth BP FiO2

Temp EtCO2

Time Health facility

Air/N2O/O2 Drug and dose Procedure 1 1 2 2 Sedationist 3 3 Operator 4 4 5 5 Recovery nurse 6 6 Medical history 200 IV cannula size 180 160 IV cannula site Previous operations/GA/sedation 140 120

100 Medication 80 Allergies 60 Blood pressure Pulse • 40 Last oral intake 20 Fluids Solids RR IV fluids Examination SpO2 Airway FiO2 Other systems EtO2 Temp Comments LOC

Critical event: Yes No Sedationist signature: Write details overleaf or on a critical incident reporting form Appendix 5b: Post-sedation monitoring chart

Post-sedation monitoring chart

Name of patient: Date: Admission 5 minutes 10 minutes 15 minutes 30 minutes 60 minutes Discharge Time

O2 given Respiratory rate

SpO2 Heart rate Level of consciousness Temperature Comments

S Afr J Anaesthesiol Analg S28 2010;16(5)(Supplement 1) Appendix 5b: Post-sedation monitoring chart Appendix 5c: Discharge scoring system

Discharge scoring system

Physical sign Clinical level Score

Fully awake/alert/answer questions 2

Level of consciousness Rousable to verbal command 1

No response 0

Able to take deep breaths and cough adequately 2

Respiration Shallow breathing with poor cough 1

Apnoeic periods 0

> 96% on room air 2

Oxygen saturation Requires oxygen to maintain saturation > 90% 1

Saturation < 90% with oxygen 0

Able to move all four extremities on command 2

Movement Able to move two extremities on command 1

Not able to move extremities on command 0

36-38 °C 2

Temperature 35.5–35.9 °C or 38.1–38.5 °C 1

< 35.5 °C or > 38.5 °C 0

Minimal discomfort or pain 2 Pain Significant pain 0

A score of 12 indicates that the patient has recovered fully and can be discharged from the recovery area. Discharge cannot be permitted if the score for any individual category is 0.

S Afr J Anaesthesiol Analg S29 2010;16(5)(Supplement 1) Appendix 5c: Discharge scoring system Appendix 5d: Discharge questionnaire

Discharge questionnaire

Name of patient: Date: Yes No

Fully awake and aware?

Breathing comfortably and colour normal?

Able to swallow and cough?

Able to walk without feeling faint/able to move extremities?

Normothermic?

Minimal discomfort or pain?

Not nauseous, or only minimal on ambulation?

Operative site checked and bleeding controlled?

Able to take fluids orally?

Post-sedation instructions given and explained to parent/guardian/responsible person, including analgesia management plan?

Possible complications explained?

Prescription or medication given?

Suitably accompanied by parent/guardian/responsible person?

Patient has been assessed and is deemed fit for discharge home at: ………………...... ….…………...………………(time and date)

Mode of transport home: ………………...... ………….…………….………………

Signature of recovery nurse:………………...... ………….……………

S Afr J Anaesthesiol Analg S30 2010;16(5)(Supplement 1) Appendix 6: Drug dosage tables

Drug dosage tables

Sedative agents

Benzodiazepines

Single agent dosing schedule of midazolam

Route of Dose Maximum dose Time to peak effect Duration of action administration Oral 0.25–0.5 mg/kg 7.5 mg 10–30 minutes 60 minutes* Sublingual 0.25–0.3 mg/kg 0.3 mg/kg 10–15 minutes 20-60 minutes* Intravenous 0.025–0.1 mg/kg** 1 mg 3–5 minutes 20-60 minutes* Rectal 0.5–0.75 mg/kg 1 mg/kg 10–20 minutes 60 minutes* Intranasal 0.2–0.3 mg/kg 0.3 mg/kg 10–15 minutes 60–120 minutes*

When used in combination with other drugs, doses should be decreased and titrated to effect * Dose-related ** Titrate to effect, repeat dose every five minutes until desired level of sedation achieved

Dosing schedule of flumazenil (benzodiazepine antagonist)

Dose Titration interval* Maximum dose Duration of action 10 µg/kg over 30 2 minutes 1 mg/kg 1 hour seconds

* Repeat dose until desired effect achieved or maximum dose reached

Anaesthetic agents

Dosing schedule of ketamine

Route of Dose Onset of action Time to peak effect Duration of action administration Sedation Oral 6-10 mg/kg > 5 minutes 30 minutes* 4–6 hours Intravenous (bolus) 0.25–1 mg/kg** < 1 minute 3–5 minutes 10-15 minutes Intravenous (infusion) 0.5–1 mg/kg/hour*** < 1 minute 3–5 minutes 10-15 minutes Intramuscular 2-4 mg/kg 2–5 minutes 20 minutes 30–120 minutes* Rectal 4–6 mg/kg > 5 minutes 30 minutes* 30–120 minutes* Analgesia Oral 4–6 mg/kg > 5 minutes 30 minutes* 4–6 hours Intravenous (infusion) 0.15–0.3 mg/kg/hr < 1 minute 3–5 minutes 15 minutes

* Dose-related ** Titrate to effect, repeat dose every three minutes until desired level of sedation achieved *** Infusion following bolus dose of 0.25–1 mg/kg

Single agent dosing schedule of propofol

Dose Onset of action Duration of action Repeat dose Titration interval 0.3–0.5 mg/kg 45–90 seconds 5 – 8 minutes 0.5 mg/kg 1 minute

S Afr J Anaesthesiol Analg S31 2010;16(5)(Supplement 1) Appendix 6: Drug dosage tables Appendix 6: Drug dosage tables

Dosing schedule of ketofol, consisting of ketamine 5 mg/ml and propofol 9 mg/ml

Route of Dose Onset of action Duration of action Repeat dose Titration interval administration Intravenous 0.05 ml/kg* 30–90 seconds 5–10 minutes 0.05 ml/kg 1–5 minutes

* Ketamine 0.25 mg/kg and propofol 0.45 mg/kg.

Alpha-agonists

Single oral agent dosing schedule of clonidine

Dose Onset of action Time to peak effect 1 – 5 µg/kg 20 – 40 minutes 60 minutes

Other sedative agents

Dosing schedule of chloral hydrate

Dose Maximum dose Onset of action Time to peak effect Duration of action 25–100 mg/kg 2 g 15–30 minutes 30–60 minutes 6–8 hours

Dosing schedule of trimeprazine

Dose Onset of action Duration of action 1–2 mg/kg 60–90 minutes 5–8 hours

Dosing schedule of droperidol

Route of Dose Duration of action administration Sedation Oral 0.05–0.2 mg/kg 2–6 hours Antiemesis Oral or intravenous 10–20 μg/kg 6 hours

Analgesic agents

Opioids

Dosing schedule of tilidine

Dose Time to peak effect Duration of action 1 mg/kg* 45 minutes 4–6 hours

* Number of drops = body weight/2.5.

Single agent dosing schedule of fentanyl

Route of Dose Onset of action Time to peak effect Maximum dose Duration of action administration Oral or transmucosal 1 – 5 µg/kg 15–30 minutes 30–45 minutes 5 µg/kg 1 hour* Intravenous 0.25 µg/kg** Immediate 3-8 minutes 2 µg/kg 30 minutes*

When used in combination with other drugs, doses should be decreased and titrated to effect * Dose-related ** Titrate to effect, repeat dose every three minutes until desired level of analgesia achieved or maximum dose reached

S Afr J Anaesthesiol Analg S32 2010;16(5)(Supplement 1) Appendix 6: Drug dosage tables Appendix 6: Drug dosage tables

Single agent dosing schedule of alfentanil

Intravenous bolus Titration interval Duration of action Infusion dose dose 0.5–1 µg/kg 2 minutes < 5 minutes 10–12 µg/kg/hour

Dosing schedule of naloxone (opioid antagonist)

Dose Titration interval* Maximum dose Duration of action 1–2 µg/kg 2 minutes 1 mg/kg 45 minutes

* Repeat dose until desired effect achieved, or recommended maximum dose reached.

Nitrous oxide

Dosing schedule of nitrous oxide

Dose (concentration Onset of action Time to peak effect administered) 50 % 30–60 seconds 3 minutes

Simple analgesics

Dosing schedule of simple analgesics

Drug Route of Dose Time to peak effect administration Paracetamol Oral 20 mg/kg 100–120 minutes Rectal 40 mg/kg 60–240 minutes Intravenous 15 mg/kg 50 – 60 minutes Ibuprofen Oral 10 mg/kg 120–240 minutes Diclofenac Rectal 1–1.5 mg/kg 30–45 minutes Ketorolac Intravenous 0.5 mg/kg 60–120 minutes

Local anaesthetics

Maximum safe doses of local anaesthetic drugs

Drug Dose with Dose without adrenaline adrenaline Lignocaine 7 mg/kg 3 mg/kg Bupivacaine 2.5 mg/kg 2.5 mg/kg

S Afr J Anaesthesiol Analg S33 2010;16(5)(Supplement 1) Appendix 6: Drug dosage tables Appendix 7: Checklist of equipment required for paediatric procedural sedation and analgesia

Checklist of equipment required for paediatric procedural sedation and analgesia

Oxygen delivery devices Masks, nebulizer masks, nasal prongs (+ CO2 monitoring) and T-piece Oxygen supply The oxygen source must be reliable and able to provide at least 90% oxygen via a self-inflating positive pressure delivery system, at 15l/minute for at least 60 minutes Oxygen and oxygen tubing With flow regulator and oxygen tubing for bag-valve device Equipment to diagnose and treat cardiac dysrhythmias ECG monitor defibrillator With conductive paste or pads, paddles, electrodes and razor Cardiac arrest board Equipment to gain intravascular access Tourniquets Alcohol skin wipes Sterile gauze pads Intravenous cannulae 18-24 gauge Needles and syringes 1-50 ml syringes Sharps container Paediatric intraosseous needles Tape Appropriate strapping and dressings for paediatric intravenous access Equipment for accurate infusion of drugs and fluids Infusion pumps Intravenous fluid administration during simple sedation Syringe drivers Drug administration during advanced sedation Intravenous administration sets Administration sets and buretrol Intravenous fluids Crystalloids and colloids Equipment for monitoring airway, breathing and circulation Stethoscope/praecordial stethoscope Pulse oximeter Adult and paediatric probes Non-invasive blood pressure monitoring device Including paediatric and adult cuffs Thermometer Including low-reading capability Blood glucose testing Capnograph Desirable but not compulsory; nasal prongs with capnography line Miscellaneous Drip stand, or equivalent suspension device Suction devices and suction catheters Including catheters for suctioning endotracheal tubes, and Yankauer-type suction nozzles Therapeutic heating source Desirable for long cases Universal precautions Including gloves Tilting operating surface or trolley Capable of Fowler’s and Trendelenberg positions Procedure lighting Adequate for intravenous access Medication stickers South African Resuscitation Council algorithms Basic Life Support (BLS), Advanced Life Support (ALS) for adults and children, anaphylaxis (www.resuscitationcouncil.co.za) management and choking Resuscitation documentation record All equipment should be checked regularly and stored in a mobile cupboard. It is critical for a roving or mobile sedation practitioner to ensure, before commencing sedation, that all of this equipment is available.

S Afr J Anaesthesiol Analg S34 2010;16(5)(Supplement 1) Appendix 7: Checklist of equipment required for paediatric procedural sedation and analgesia Appendix 8: Paediatric pre-procedural checklist

Paediatric pre-procedural checklist

Name of patient: Date: Yes No

1. Has the medical history questionnaire been completed?

2. Has the child been evaluated by the sedation practitioner?

3. Have there been any changes in the patient’s medical condition since the first evaluation? If the answer is “yes”, please provide details:

4. Have contraindications for sedation been excluded?

5. Has the child been examined for signs of an upper respiratory tract infection?

6. Does the child have any allergies?

7. Has the child fasted for the recommended period of time?

8. Has written, informed consent been obtained?

9. Has the child been administered premedication? If the answer is “yes”, please provide details, including the name of the practitioner who ordered it:

10. Have all equipment, including airway equipment and monitoring devices, and drugs been checked?

………………………….…………….……………… ………………………….…………….……………… Signature (Sedation provider/practitioner) Date

S Afr J Anaesthesiol Analg S35 2010;16(5)(Supplement 1) Appendix 8: Paediatric pre-procedural checklist Appendix 9: Critical incident reporting form: paediatric procedural sedation and analgesia

Critical incident reporting form: paediatric procedural sedation and analgesia

General instructions

• A critical incident is any event which affects, or could affect, the safety of the patient. This event could be either preventable or unpreventable. • Identify the patient and the sedationist(s). • Record the patient’s details: age, weight and state of health. • Provide a simple description of events. • For medicolegal purposes: −− Do not assume culpability. −− Simply provide a description of the sequence of events in your own words. −− Include details which may have contributed to or minimised the event. −− Suggest what could be done to prevent further events of this nature (e.g. monitors, drugs). −− If more than one event occurred, provide a detailed report of each. • State whether you think the event was avoidable: yes, no, or undecided (maybe).

Classification of a critical incident

What was the cause of the event? Circuitry Equipment Pharmacological

Why did the event occur? Factors that may have contributed to the event:

Factors that may have minimised the event:

Suggested corrective measures:

Describe the medications Procedure: Emergency Elective administered and the procedure performed: Monitors:

Type of sedation:

When and where did the event Time: Day: Month: Year: take place? Waiting area Theatre Procedure room Recovery room Ward

When were you alerted to the Pre-sedation Sedation Sedation Emergence Recovery event? induction maintenance

Provide the patient’s details: Name: ID: ASA status 1 2 3 4 5 E

Neonate < 1 year 1-8 years > 8 years

What was the immediate patient Cardiac arrest Major resuscitation Minor resuscitation Physical injury outcome?

What was the final patient Awareness Death Major Minor Prolonged ICU or outcome? morbidity morbidity hospital stay high care

Was the sedationist debriefed? Yes/No Details:

S Afr J Anaesthesiol Analg S36 2010;16(5)(Supplement 1) Appendix 9: Critical incident reporting form: paediatric procedural sedation and analgesia Appendix 9: Critical Incident Reporting Form: Paediatric Procedural Sedation and Analgesia

Critical incident report (including near-misses)

Patient details (or patient sticker):

Procedure:

Date and time of event:

Sedationist(s) present:

Brief and relevant details of the event: (Including nature of incident, action taken and final outcome)

Reporting sedationist

Name:

Signed: Date:

Date of meeting where incident discussed:

Additional comments/further action taken:

Chairperson of the meeting:

Name:

Signed: Date:

S Afr J Anaesthesiol Analg S37 2010;16(5)(Supplement 1)