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