In 2004 and 2008, the ACEP published evidence-based guidelines on the use of specific medications for use in pediatric sedation: “Clinical policy: evidence-based approach to pharmacologic agents used in pediatric sedation and analgesia in the emergency department” [5] and “Clinical policy: Critical issues in the sedation of pediatric patients in the emergency department” [28]. The “Critical Issues” statement supported earlier recommendations on NPO status and reviewed the use of sedatives including nitrous oxide, chloral hydrate, and sucrose. Their recommendations have been accepted by a wide range of surgical and nursing organizations and have been published in corresponding journals [30, 31].
Other ACEP publications include a clinical practice advisory on propofol use in the emergency department [25], and a clinical practice guideline on ketamine use in the emergency department [6]. Both of these documents support the use of these drugs for sedation in the emergency department, expanding on the evidence-based guideline recommendations from the clinical policy on pharmacological agents mentioned previously [5]. The ACEP recommendations for physiological monitoring also differ from the ASA and AAP with respect to pulse oximetry application: Pulse oximetry is not mandatory. The guidelines advise that pulse oximetry may not be necessary when the patient’s level of consciousness is minimally depressed and verbal communication can be continually monitored. Pulse oximetry is recommended, however, when there is an increased risk of developing hypoxemia, such as when high doses of drugs or multiple drugs are used, or when treating patients with significant comorbidity. Capnography, although not required, is acknowledged to be a monitor that may allow more rapid identification of hypoventilation than pulse oximetry alone [32].
In February 2014, the ACEP released the most recent clinical policy to date. Entitled “Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department,” it updates the 2005 policy [33]. This paper highlights the value of designing studies to specifically examine patient-specific outcomes. It also recognizes that unique patient-care environments and high-risk patient populations may pose unique challenges which may require modification of the clinical policy. Reviewing the literature, the College of Emergency Physicians Clinical Policies Committee made evidence-based recommendations for important clinical questions. The following questions were addressed [33]:
1.
Is preprocedural (nil per os/NPO) fasting necessary to decrease risk of emesis and aspiration during sedation in the emergency department?
2.
Does capnography decrease risk of adverse events?
3.
How many personnel are necessary to manage sedation-related complications?
4.
Are ketamine, propofol, etomidate, dexmedetomidine, alfentanil, and remifentanil appropriate sedatives for the emergency department?
The clinical policy was based on literature review, with recommendations identified as levels A, B, and C. The levels were determined from the degree of clinical certainty after review of the literature. High certainty, moderate certainty, and inadequate/absence evidence corresponded to levels A, B, and C recommendations, respectively. The importance of NPO was a level B recommendation, advising that there was no evidence to support preprocedural fasting of children for procedural sedation in the emergency department. The routine use of capnography was assigned a level B recommendation, recognizing that as an adjunct to pulse oximetry, it may detect hypoventilation and apnea earlier than pulse oximetry or clinical assessment. The recommendation for the number of personnel necessary to manage sedation-related complications was a level C—without supporting evidence, the recommendation was that in addition to the provider performing the procedure, a nurse or other qualified individual needed to be continuously present. The final recommendations with respect to sedatives were levels A, B, and C. Ketamine and propofol were considered level A recommendations, deemed safe for pediatric sedation in the emergency department. Etomidate for children was considered level C, supported with expert consensus, despite absent/inadequate supporting published literature. The combination of ketamine and propofol was considered level B for safe pediatric sedation in the emergency department. No recommendations could be made for dexmedetomidine, as there is only one case report of its use in the emergency department.
American Dental Association Sedation Guidelines
The American Dental Association (ADA) guidelines regarding sedation are posted on its website [34]. The guideline acknowledges the depths of sedation consistent with that described by the AAP and the ASA. It contains descriptions of routes of administration for sedative medications, ASA classification for sedation patients, and monitoring guidelines for sedated patients. There is a very specific outline of the training required for dentists regarding various levels of sedation, including specific educational programs and life support training. In this regard, the guidelines are more detailed than those provided by other organizations. Deep sedation requires the presence of a minimum of three individuals: one dentist who is credentialed to administer deep sedation or anesthesia and two additional personnel who have current certification of successfully completing a Basic Life Support (BLS) Course for the Healthcare Provider. There are two requirements to qualify for deep sedation certification: (1) completion of an advanced education program on the administration and management of deep sedation or anesthesia, which must be accredited by the ADA Commission on Dental Accreditation, and (2) a current certification in both BLS for Healthcare Providers and ACLS or an appropriate dental sedation/anesthesia emergency management course. The dentist administering deep sedation or general anesthesia must remain within the facility until the patient meets discharge criteria (or is discharged) and must monitor the patient continuously until the patient meets the criteria for recovery. Those who provide pediatric sedation must have PALS in addition to directed pediatric training and education [35, 36].
The guidelines are presented in sections, each of which relates to a sedation level: minimal, moderate, and deep sedation. Specific recommendations are given for training of sedation providers, preoperative preparation of patients, monitoring and documentation, recover and discharge criteria, and personnel/equipment requirements. For children 12 years of age and under, the ADA refers to the AAP/American Academy of Pediatric Dentists (AAPD) Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures that was discussed earlier in the AAP section [3, 37]. These guidelines address some issues unique to the office-based dental practice and to the special needs child. If the dental patient is mentally and/or physically challenged, it may not be possible to have a comprehensive physical examination or appropriate laboratory tests prior to administering care. In these situations, the dentist responsible for administering the deep sedation should document the reasons preventing the recommended preoperative assessment prior to administering sedation [3]. In addition, recognizing the long history of nitrous oxide use in dentistry, this document specifically mentions it as an acceptable sedative, alone or in combination with other sedatives [3].
In 2012, AAPD published a revision of its “Guideline on Use of Anesthesia Personnel in the Administration of Office-based Deep Sedation/General Anesthesia to the Pediatric Dental Patient” [38]. This document reaffirms the fact that there are several categories of pediatric patients, such as those with developmental delays and autism, who require deep sedation for dental interventions. It further recognizes that when this care is provided in the dental office, it is much more cost effective and convenient to schedule than when it is delivered in a large hospital setting. The authors are careful to define the aspects of training that are required in order to deliver this care. Specifically, the provider must have completed a 1- or 2-year dental anesthesia residency approved by the ADA or a medical anesthesia residency as approved by the AMA. This provider must be licensed in the state where the care is provided. Emergency preparedness must be updated and practiced on a regular basis and recovery must be monitored by an experienced provider at all times until the patient has met discharge criteria. There is a directive that the facility must meet the standards for anesthesia delivery as set by state or local codes and the “Guidelines on Monitoring and Management of Pediatric Patients During and after sedation for Diagnostic and Therapeutic Procedures.” The new document concludes by reinforcing the need for appropriate pre-, intra-, and postoperative documentation as well as ongoing quality assurance standards.
American Society of Gastroenterologists
The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy has recently published guidelines for deep sedation, the administration of propofol by nonanesthesiologists, and pediatric sedation for gastrointestinal procedures and endoscopy [39]. All of these guidelines were written after a review of the MEDLINE and PubMed database. The recommendations are rated “A,” “B,” or “C” based on the weight of the evidence available. A level identifies statements supported by prospective randomized trials and C level identifies expert opinion in the absence of peer-reviewed evidence. The chronological history leading up to these 2009 guidelines will be detailed as follows.
The first guideline was published in 2002 and entitled “Guidelines for the Use of Deep Sedation and Anesthesia for GI Endoscopy” [40]. This guideline reviews the levels of sedation and the importance of presedation assessment in order to customize sedation for the needs of the patient. Planning is identified as particularly important for those with specific emotional issues, drug use history, and those who are undergoing extensive procedures. There are no specific references to or recommendations for the pediatric population.
Pharmacologic agents are reviewed including guidelines for the indications and use of droperidol (in addition to midazolam and fentanyl) and propofol for deep sedation during endoscopy. This guideline is unique in its recommendation for droperidol as a third drug if needed. There is an accompanying warning about cardiac issues related to droperidol and the need for extended ECG monitoring when it is utilized.
The majority of this guideline is devoted to the role of propofol and the relative risks versus benefits of its use in endoscopy. Personnel preparation and monitoring requirements for propofol sedation are carefully delineated [40]:
1.
At least one person who is qualified in both basic and advanced life support skills (i.e., tracheal intubation, defibrillation, use of resuscitation medications).
2.
Physiologic monitoring should include pulse oximetry, electrocardiography, and automated blood pressure measurement. Monitoring oxygenation by pulse oximetry is not a substitute for monitoring ventilatory function.
3.
Equipment for airway management and resuscitation.
4.
Trained personnel dedicated to the continuous and uninterrupted monitoring of the patient’s physiologic parameters and administration of propofol.
5.
Extended monitoring with capnography should be considered as it may decrease the risks during deep sedation.
Published in 2002, it concludes that although propofol does not appear to offer a significant advantage over standard benzodiazepine/opiate techniques for routine endoscopy procedure, it does confer significant advantages for longer and more complicated procedures (level “A” recommendation). The authors also discuss the provision of propofol sedation by nonanesthesiologists including other physicians and registered nurses. Anesthesiology assistance is recommended for specific situations including: prolonged or therapeutic endoscopic procedure requiring deep sedation, anticipated intolerance to standard sedatives, increased risk for complication because of severe comorbidity (ASA class III or greater), increased risk for airway obstruction because of anatomic variant. These final recommendations are included at a “C” level.
A second publication, “Guidelines for Conscious Sedation and Monitoring during Gastrointestinal Endoscopy,” was published in 2003 in the journal Gastrointestinal Endoscopy [41]. It refers to “conscious sedation” as a level of equivalence to “moderate sedation.” These guidelines review the data on endoscopy-related complications—noting that over 50 % of complications are related to cardiopulmonary side effects with the majority relating to aspiration, oversedation, hypoventilation, vasovagal episodes, and airway obstruction. The authors note that the risk of cardiovascular complications is dependent on the patient’s underlying medical condition and the procedure to be performed—high-risk patients and high-risk procedures at highest risk.
These guidelines support the monitoring recommendations of the ASA and AAP. Required monitoring during sedation for endoscopy includes recording of the heart rate, blood pressure, respiratory rate, and oxygen saturation. Capnography is advised for prolonged cases.
Several drugs are mentioned for conscious sedation during endoscopy. Benzodiazepines and opiates (along with reversal agents) are reviewed along with droperidol and promethazine. Unique to this set of guidelines, “pharyngeal” anesthesia is reviewed. Specific mention is made of the risk of methemoglobinemia when excessive benzocaine is administered to the mucosa. In reference to deep sedation, the authors suggest that propofol is superior to standard benzodiazepine/opiate sedation for complex procedures. On the other hand, the authors recognize that its use in routine upper and lower endoscopic procedures is controversial with little proven benefit over standard moderate sedation [41].
The most recent and pertinent publication regarding sedation specifically for pediatric endoscopy was published in 2008 as “Modifications in Endoscopic Practice for Pediatric Patients” [42]. This document addresses many issues relating to sedation in children and for pediatric endoscopy. For example, the authors review indications and contraindications for endoscopy in children, the appropriateness of pediatric versus adult endoscopists for various procedures in children, and the appropriate preparation of patients for these studies. They include discussions of the proper equipment to use for pediatric endoscopy and the indications for antibiotic prophylaxis.
Important cautions are included, such as the fact that airway obstruction is more common in children and (because of higher oxygen consumption) can lead to the rapid onset of hypoxia in the face of apnea. Therefore the routine use of oxygen is recommended during endoscopic sedation in this age group. The authors note that general anesthesia is often used for pediatric endoscopy and that the number of centers using propofol sedation or general anesthesia for endoscopy appears to be increasing [42, 43]. One study from 1995 cites equivalent safety and efficacy when using a standardized procedural sedation protocol (opiate plus benzodiazepine) when compared to general (potent inhalation) anesthesia [44]. The authors also note that when propofol is compared to “general anesthesia” it has been found to result in less total time for anesthesia and equal safety [45].
In 2009, the American Society of Gastroenterologists (ASG) published their position statement for nonanesthesiologist administration of propofol for GI endoscopy [39]. The guidelines state that clinically important benefits of propofol in average-risk patients undergoing upper endoscopy and colonoscopy have not been consistently demonstrated with regard to patient satisfaction and safety. It supports that propofol can be safely and effectively given by nonanesthesiologist physicians and nurses provided they have undergone appropriate training and credentialing in administration and rescue from potential pulmonary and cardiovascular complications. The summary section makes specific recommendations for sedation for pediatric endoscopy. They generally follow AAP and ASA standards [39]:
1.
All sedation pediatric patients should receive routine oxygen administration and should be monitored with a minimum of pulse oximetry and heart rate monitoring.
2.
In deeply sedated patients, one individual having no other responsibilities should be assigned to monitor the patient’s cardiac and respiratory status and to record vital signs.
3.
The presence of personnel trained specifically in pediatric life support and airway management during procedures requiring sedation is strongly recommended.
International Guidelines
A wide variety of sedation guidelines specific to pediatrics, or with application to pediatrics, have been published by various specialty societies and international organizations. Most of these guidelines are consistent with the recommendations from the AAP and ASA, others are not. Of particular interest are the recommendations on effective and safe sedation of children and young people undergoing common diagnostic and therapeutic procedures from the National Institute of Health and Clinical Excellence (NICE) in the United Kingdom (2011) [46]. This document was written after a comprehensive review of the best available evidence and expert opinion. The recommendations are wide ranging and include the mandate for a full presedation evaluation that incorporates medical condition, current medications, airway assessment, ASA physical status, and an evaluation of the psychosocial makeup of the child. In addition, there is a clear outline of indications for seeking advice from a specialist before undertaking sedation based on the presedation assessment. These referral indications include ASA status 3 or greater, airway difficulties, and all infants and newborns. Notably, these recommendations include an extensive description of available sedation techniques. The authors include a section that recommends specific drugs and drug combinations for sedation encounters based on the targeted level of sedation, the procedure, and patient/family preference. Contraindications for sedatives are also covered. Recommendations concerning other elements of sedation practice, such as choosing appropriate resuscitation equipment, personnel, and informed consent, follow closely with the guidelines put forward by the AAP and ASA.
Chapters 18 and 25 detail the most recent sedation guidelines from the Dutch Institute of Healthcare Improvement in the Netherlands (2011) [47], the Endoscopy Section of the German Society for Digestive and Metabolic Diseases (2009) [48] and the adult and pediatric guidelines of the South African Society of Anesthesiologists (2010 and 2011) [49, 50].
Notable sedation statements and guidelines published worldwide include:
Scottish Intercollegiate Guidelines Network. “SIGN Guideline 58: safe sedation of children undergoing diagnostic and therapeutic procedures” [51]
This is a comprehensive, evidence-based sedation review that includes discussions of appropriate evaluation of pediatric patients as well as recommendations for equipment, environment, recovery, parental information, and quality improvement. There are specific sections addressing the needs of medical pediatrics versus dentistry versus radiology versus emergency medicine. There is also a section on sedation techniques that recommends various drugs for certain situations and specifically reserves potent medications such as propofol and short-acting opiates for use by anesthesiologists.
Australasian College for Emergency Medicine, Australian and New Zealand College of Anesthetists. “Statement on clinical principles for procedural sedation” [52]
A very brief statement of basic principles of sedation (preparation, staffing, facilities, medication, recovery) that is in line with recommendations from British and American organizations. Source material is not referenced.
Canadian Consensus Guidelines. Canadian Association of Emergency Physicians “Procedural sedation and analgesia in the emergency department” [53]
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