Paediatric Sedation Guidelines For Procedural Sedation And .
ISSN-2220-1181SOUTH AFRICAN SOCIETYOF ANAESTHESIOLOGISTS (SASA)Paediatric Sedation Guidelines forProcedural Sedation and Analgesia
1SASA Paediatric Guidelines for Procedural Sedation and AnalgesiaForeword to the second edition of the SASA Paediatric Guidelinesfor Procedural Sedation and Analgesiacomponents of clinical governance and the need for log books,accreditation of practitioners and facilities, recommending thepresence of an observer to monitor and help rescue patientsduring a critical event, and to recommend connected supervisedclinical training in paediatric sedation and analgesia. Severaldefinitions as well as Appendix 9 (Practice appraisal protocol)have been adapted directly from the adult guidelines and wethank the authors of these guidelines for permitting us to do this.When the first edition of the Paediatric Procedural Sedationand Analgesia Guidelines was published in 2010, it was theculmination of over one year’s worth of extensive interdisciplinary consultation. This updated edition builds on thework of the first edition and includes a thorough revision andupdating of the definitions of sedation, pharmacology andmonitoring for paediatric procedural sedation and analgesia. It isthe work of Professor James Roelofse and Dr Rebecca Gray withinput from Professor Jenny Thomas and Dr Marianna de Kock.Accreditation for standards of practice for the provision ofsedation and analgesia for children is necessary, and is imminent.Non-pharmacological strategies and psychological preparationare also important considerations for this practice. Each of thesehas been addressed in this document. One of the changes of thisedition involves the removal of “recipes” of drug administrationfor particular procedures, as this information is part of thesupervised clinical training programs which are offered in mostprovinces.Our aim with these guidelines is to provide a reference for goodclinical practice for all health care practitioners who providesedation and analgesia for children undergoing painful or nonpainful therapeutic or diagnostic procedures. We also aim topromote good clinical governance in all matters concerningpaediatric sedation whether a procedure is undertaken ina physician’s office, a remote facility or an operating room.These guidelines are based on national and international peerreviewed publications as well as on many years of paediatricsedation experience. The standards outlined in these guidelinesare appropriate and achievable and will guarantee high levels ofsafety.The term “sedation practitioner” will replace all previousterminology, and describes the health professional providingsedation analgesia to children. He or she requires adequatesupervised clinical training in order to minimise risk to thepatient. Sedation is not the same as anaesthesia, and this subjectmay be something we should address during our training ofspecialist anaesthesiologists.In the development of this new edition, the approach was toidentify what is new in paediatric sedation and analgesia: newtechniques, novel drugs and therapies, and to scrutinise otherinternational paediatric sedation and analgesia guidelines; torevise some areas of practice – definitions, drug recipes; and learnfrom some of the changes made in the adult guidelines i.e. safetywww.tandfonline.com/ojaaWe wish all readers success in the practice of this difficult butvery necessary service to the children of South Africa.S1The page number in the footer is not for bibliographic referencing
Southern African Journal of Anaesthesia and Analgesia 2016; 22(1)(Supplement 5):S00-S00South Afr J Anaesth AnalgISSN 2220-1181EISSN 2220-1173 2016 The Author(s)Open Access article distributed under the terms of theCreative Commons License [CC BY-NC-ND .0PAED SEDATION GUIDELINESGuidelines for the safe use of procedural sedation and analgesia for diagnosticand therapeutic procedures in childrenAll health care professionals participating in the administration, monitoring and recovery of patients requiring procedural sedationand 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.1. Introduction Patients requiring intensive care sedation. Prescription of sedation for palliative care.Providing safe and effective sedation of children requires childappropriate equipment, drugs and monitors as well as thoughtfulselection of patients suitable for sedation. Sedation in the home setting. Premedication for patients undergoing general anaesthesia. Night sedation.The aim of this document is to provide a reference that willenable all sedation practitioners to act within a framework toensure patient safety and successful performance of procedures.2. Objectives of procedural sedationand analgesiaThese guidelines are intended for use by all medical practitionersin order to provide safe sedation, analgesia and anxiolysis forchildren in all environments. Identification of those childrenunsuitable for PSA is crucial, and many of the sedation techniquesutilised in adults are not recommended for paediatric practice.PSA must provide a safe environment for the patient, and theresult must be effective control of pain, anxiety and movementin children undergoing procedures. Decreased awareness andamnesia are added advantages.These guidelines will:In some circumstances, a short general anaesthetic may providea quicker, more controllable, more reliable and safer optionfor the completion of the procedure/investigation. This wouldrequire skills, monitoring and environment appropriate to theadministration of a general anaesthetic. Define the terms used in PSA. Provide guidance on appropriate patient selection. Discuss drugs recommended for PSA. Specify equipment essential for PSA. Provide recommendations for monitoring, based on thesedation method utilised.3. Clinical governance Specify discharge criteria after PSA.Attention to environmental factors is essential for the safepractice of PSA, and is also a basic requirement for ensuring asatisfactory outcome for both the patient and the procedure.It is recommended that an annual audit of the proceduresperformed be conducted, and that this process includes a reviewof all critical adverse events.Clinical governance is a system whereby healthcare organisations, providers, and sedation societies are accountablefor continuously improving the quality of their services andsafeguarding high standards of care. An environment must becreated in which clinical excellence flourishes. The sedationpractitioner should have a framework of accountability that willinclude clinical accountability for the maintenance of expertise,updating of knowledge and skills, clinical appraisal and theimplementation of SASA guidance on procedural sedation andanalgesia for children.These guidelines are applicable to paediatric patients undergoingpainful or non-painful diagnostic or therapeutic procedures.They are not applicable to:The sedation practitioner must have a plan for each sedationevent for which he or she delivers a service. This should includedetails of the assessment protocols, the structure of the treatment Provide examples of the recommended documentation tocomplete and keep before, during and after PSA.www.tandfonline.com/ojfpS2The page number in the footer is not for bibliographic referencing
3SASA Paediatric Guidelines for Procedural Sedation and Analgesiasessions, the roles of the team members and the systems in placefor reporting adverse events. In-house training sessions for theentire sedation team should take place on an ongoing basis.because of depressed spontaneous ventilation or drug-induceddepression of neuromuscular function. Cardiovascular functionmay be impaired.Practitioners involved in sedation practice should keep acomprehensive logbook of cases performed under sedation,and are required to keep a documentary record of adverseincidents and accidents. Sedation practitioners are required tobe registered as medical practitioners by the Health ProfessionsCouncil of South Africa (HPCSA), and are required to comply withcurrent safety regulations of the HPCSA.4.2 Non-dissociative oids,benzodiazepines, barbiturates, etomidate and propofol) operateon the sedation dose-response continuum. Higher dosesprovide progressively deeper levels of sedation with possiblerespiratory and cardiovascular compromise, central nervoussystem depression, and unconsciousness. With the use of nondissociative drugs, the key to minimising adverse events is thecareful titration of drugs to the desired effect.It is highly recommended that a sedation practice and facilityin which the practice administers sedation, meet the basicstandards outlined in Appendix 9 (Practice Appraisal Protocol)prior to administering sedation for the first time and that such anappraisal is carried out regularly.4.3 Dissociative sedationDissociative sedation, produced by ketamine, causes a trancelike cataleptic state characterised by intense analgesia, amnesia,sedation, retention of protective reflexes (as deeper levelsof sedation are reached, airway reflexes may be obtunded),spontaneous breathing and cardiovascular stability. It is believedthat, when ketamine is administered in dissociative doses, it doesnot operate on the sedation continuum.It is recommended that: Facilities undergo regular inspections to comply with qualityassurance policies and procedures. Records are kept of staff training for persons involved inadministering sedation, as well as evidence of life supporttraining i.e. Basic Life Support (BLS). Evidence should be available of the training of a sedationpractitioner, including the possession of advanced life supportcertification e.g. Paediatric Advanced Life Support (PALS),Advanced Paediatric Life Support (APLS).4.4 Sedation end points4.4.1Minimal sedation is a drug-induced state during which thepatient responds normally to verbal commands. Cognitivefunction may be impaired, but ventilatory and cardiovascularfunctions are unaffected.4. DefinitionsThe definition of PSA encompasses a continuum of altered stateof consciousness, varying from minimal sedation and anxiolysisto deep sedation.4.4.2Moderate sedationModerate sedation is a drug-induced depression of consciousness during which the patient responds purposefully to verbalcommands, either alone or accompanied by light, tactilestimulation. No interventions are required to maintain a patentairway and spontaneous ventilation is adequate.The response of individual patients to the administration ofsedatives is difficult to predict. The drugs used, the dosagesadministered, the additive effects of concomitant drugs and thepatient’s pharmacogenetic profile will all impact on the depth ofsedation. An unexpected progression of the depth of sedationmust therefore be anticipated, and practitioners must be ableto rescue patients who enter a deeper level of sedation thanintended.4.4.3Deep sedationIn accordance with the Guidelines for Practice issued by SASA,deep sedation is considered part of the spectrum of generalanaesthesia, and should only be performed by those withanaesthetic training.If the patient fails to respond to verbal commands and/or lighttouch, the standard of care must be identical to that for generalanaesthesia. Guidelines for the care of the anaesthetised patientare provided in the publication Guidelines for Practice issued bythe South African Society of Anaesthesiologists (SASA), and arenot addressed in this document.Deep sedation is a drug-induced depression of consciousnessduring which patients cannot easily be roused, but may respondpurposefully following repeated or painful stimulation. Reflexwithdrawal from a painful stimulus is not considered to be apurposeful response. Deep sedation may be accompanied byclinically significant ventilatory depression. The patient mayrequire assistance maintaining a patent airway and positivepressure ventilation may be necessary. Cardiovascular functionis usually maintained. This level of sedation is termed “monitoredanaesthesia care” in certain international sedation guidelines.4.1 General anaesthesiaGeneral anaesthesia is a drug-induced loss of consciousnessduring which patients cannot be roused, even by painfulstimulation. The ability to maintain independent ventilatoryfunction is impaired. Patients require assistance in maintaining apatent airway, and positive pressure ventilation may be requiredwww.tandfonline.com/ojaaMinimal sedationS3The page number in the footer is not for bibliographic referencing
4Southern African Journal of Anaesthesia and Analgesia 2016; 22(1)(Supplement 5):S00-S00Safe sedation practice dictates that a patient in a deeply sedatedAdvanced sedation techniques require the attendance of astate be in the care of a team including a dedicated sedation-dedicated sedation practitioner and should not be performed bytrained anaesthetist or an appropriately trained sedationoperator sedation practitioners.practitioner, a trained observer with life support training and4.6 Failed sedationthe operator (performer of the procedure for which sedation isrequired).Failed sedation is defined as the failure to achieve the desired4.5 Sedation techniqueslevel of sedation, such that the procedure has to be abandoned,The sedation practitioner should be aware that there are a varietyreasons for failure include inadequate pre-sedation assessment,of options available to manage anxiety in order to facilitate carepatient factors, drug factors, or procedure-related and operatorof the patient. Procedural sedation and analgesia is just onefactors. A previous episode of failed sedation will necessitateoption for the control of anxiety. The different options includingthat the child be carefully assessed, and consideration be givenbehavioural management should be explained to patient/for the provision of general anaesthesia rather than sedation foror the need arises to convert to general anaesthesia. Possiblecaregiver before a decision is made about which techniquefuture procedures.is used.4.7 Prolonged sedationSedation techniques should only be used by those sedationpractitioners with the necessary theoretical, and supervisedThe aim of reducing costs and avoiding long theatre waitingclinical training, and life support training.times has resulted in an escalation in the demand for procedures4.5.1to be performed outside the operating theatre. Frequently, theseSimple/standard sedationprocedures are quite lengthy and may require the provision ofmoderate sedation and analgesia, or even deep sedation.Simple/standard sedation is induced by a single agent and not acombination of single agents, for example:Sedation practitioners are increasingly faced with decisions Oral, transmucosal (excluding transmucosal dexmedetomidine)about how long a patient can be kept safely sedated outside theor rectal drugs, e.g. a small dose of an oral benzodiazepine,operating theatre. Prolonged sedation in lengthy proceduresusually midazolam; orcarries increased risk and mechanisms must be instituted to Inhalation of nitrous oxide (N2O) in at least 50% oxygen; orensure the safety of patients. Currently, there is no guidance for A titrated intravenous dose of midazolam.sedation practitioners on the definition of prolonged sedation.It is recommended that any sedation procedure in childrenSedation can no longer be considered simple or standard oncelasting more than 1.5 hours for procedures performed outsideadditional agents become necessary, and the depth of sedationthe hospital should be defined as prolonged sedation. Anymay not be advanced unless the patient is fasted.procedure lasting longer than 1.5 hours is probably best stagedSimple/standard sedation techniques can be used by operatorinto two different procedures, although this approach maysedation practitioners when all the requirements for safenot be practical. The recommendation for a procedure that ispractice have been met e.g. training, an observer to monitorexpected to last more than 1.5 hours is to perform the procedureand help with rescue if indicated, and premises that meet theunder general anaesthesia in the hospital.requirements for safe practice.4.5.24.8 Sedation for special needs in childrenAdvanced sedationThis is generally applicable to children whose disabilities affectAdvanced sedation is induced by one of the following techniques:the provision of care, and frequently applies to dental hygiene. Any combination of drugs, administered by any route; orSedation for patients with disabilities must only be undertaken Any sedation administered by the intravenous route, usingby trained sedation practitioners with experience in sedatingpatients with special needs. It may be extremely difficult tobolus or infusion techniques; orjudge the level of sedation. Deeper levels of sedation are Any inhalational sedation (e.g. sevoflurane), with the exceptionusually needed to treat this group of patients. Adaptations toof N2O used as the sole agent in a concentration of less thanthe treatment protocol may be necessary e.g. more treatment50% in oxygen.sessions under sedation.Advanced sedation can include both dissociative and non-4.9 American Society of AnesthesiologistsPhysical Status Classificationdissociative techniques.Advanced sedation techniques should only be performed bythose sedation practitioners who have had the necessary clinicalThe American Society of Anesthesiologists (ASA) Physical Statusand life support training.Classification System is tabulated below (Table I):www.tandfonline.com/ojaaS4The page number in the footer is not for bibliographic referencing
5SASA Paediatric Guidelines for Procedural Sedation and Analgesia Age 1 year.Table I: American Society of Anesthesiologists (ASA) Physical StatusClassification SystemClass IA normal healthy patientClass IIA patient with mild systemic disease and no functionalincapacityClass IIIA patient with severe systemic disease that limits activity,but is not incapacitatingClass IVA patient with severe systemic disease that is a constantthreat to lifeClass VA moribund patient not expected to survive 24 hourswith or without an operation“E”An emergency procedure is denoted by the letter Efollowing the class number Prematurity with residual pulmonary, cardiovascular,gastrointestinal or neurological problems, or significantanaemia. Children with congenital syndromes. Obesity ( 95th percentile body mass index (BMI) for age). Children who need an advanced sedation technique. A previous failed sedation. A previous over-sedation (unintentional deep sedation orgeneral anaesthesia). Any known adverse effect (hyperactive or paradoxicalresponse) or allergy to any of the sedation drugs. Any child who, following airway assessment, is suspected ofhaving airway problems (see table II).4.10 Active upper respiratory tract infection Children with respiratory problems, including an active URTI,low oxygen saturation, and a weak cough or cry.An active upper respiratory tract infection (URTI) is current orrecent when two or more of the following symptoms or signs are Asthmatic children who are clinically wheezing or whoseregular treatment includes more than inhalational shortacting ß2–agonists and inhalational steroids.still present: Rhinorrhoea Sore or scratchy throat Children with cardiac problems, including congenital cardiacdisease, cyanosis, congestive heart failure and undiagnosedmurmurs. Sneezing Nasal congestion Neurological conditions, including poorly-controlled seizures,neuromuscular disease, central apnoea or an unstable cervicalspine. Malaise Cough Fever Increased intracranial pressure. Unexplained tachycardia Severe behavioural problems. If a parent/carer reports or is concerned that the child is sickAirways rem
of all critical adverse events. These guidelines are applicable to paediatric patients undergoing painful or non-painful diagnostic or therapeutic procedures. They are not applicable to: Patients requiring intensive care sedation. Prescription of sedation for palliati
Paediatric Clinical Practice Guideline Paediatric Clinical Practice Guideline – Procedural sedation Page 3 of 7 Members of the team must have the following life support skills: Minimal sedation Moderate sedation Deep sedation All members Basic Basic Basic At least one member Intermediate Advanced
from the ASA Committee on Practice Parameters. This Practice Guideline is an update and revision of the ASA “Guidelines for Sedation and Analgesia by Non-Table 1. Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia Minimal Sedation (Anxiolysis) Moderate Sedation/Analgesia
Moderate Procedural Sedation: Preparing for Procedural Sedation. 8 (Patient Teaching, cont’d) Pre-Procedure Fasting Instructions Elective Procedures Because sedatives & analgesics tend to impair airway reflexes in proportion to the degree of sedation/analgesia achieved, the following fasting guidelines should be followed: Adult Patient 1.
clinical practice guidelines have replaced the word conscious with moderate to address differences that occur within the continuum of sedation. The terms moderate se-dation and procedural sedation are now used interchangeably. Over the last several decades, procedural sedation and analgesia for surgical, therapeutic, and diag-
The American Society of Anesthesiology (ASA) created practice guidelines for non-anesthesiologists who provide sedation and analgesia. This was followed by development of ACEP clinical policies and similar policies and statements by other professional organizations regarding moderate sedation and procedural sedation. 17
1. Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist
Practice guidelines for moderate procedural sedation and analgesia 2018. A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American .
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