Recommendations for procedural sedation in infants, children, and adolescents

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Infants, children, and adolescents often require sedation for diagnostic tests and therapeutic procedures. The goal of procedural sedation is to minimize distress, physical discomfort, or pain while maintaining airway reflexes, adequate oxygenation and ventilation, and cardiopulmonary stability, reflected by limited deviation from baseline vital signs. The expanding literature on procedural sedation includes guidelines from the American Academy of Pediatrics (AAP) ^[1][2], the formation of the Paediatric Sedation Research Consortium ^[3], and numerous other publications ^[4]-[7].

Adverse events associated with procedural sedation are rare ^[6][8]-[11], but can result in significant morbidity and mortality ^[12]. The vast majority of events are preventable, and risk is minimized when patients are carefully selected, prepared, and monitored ^[12]. Procedural sedation should only be performed by clinicians who are trained and experienced in procedural sedation, advanced airway management, and paediatric resuscitation. Personnel, equipment, and medications for resuscitation must be immediately available regardless of the pharmacologic agent(s) chosen or the anticipated depth of sedation because individual responses to medications can be unpredictable ^[13].

This statement provides best practice guidance for the development of institutional standards surrounding safe procedural sedation for infants, children and adolescents (Figure 1). The term ‘procedural sedation’ refers here to the administration of any pharmacologic agent(s) for the purpose of sedation. Guidance in this document does not necessarily apply to patients receiving medications for anxiolytic purposes or analgesic drugs for pain. Such cases are described in another Canadian Paediatric Society statement on managing pain and distress in children undergoing brief diagnostic and therapeutic procedures.

Figure 1. Practice algorithm for procedural sedation in paediatric patients is available as a supplementary file.

Clinician skills, training, and credentialing

Procedural sedation can be safely administered by non-anesthesiologist clinicians in both tertiary care and community hospitals ^[8]-[11][14]. Safety and effectiveness relate primarily to individual clinicians’ skills ^[15], and a practitioner competent in airway management and the resuscitation and stabilization of critically ill paediatric patients must be immediately available at all times ^[12]. The clinician responsible for administering sedation must be prepared to manage emergency situations including aspiration, airway obstruction, laryngospasm, apnea, hypoventilation, hypoxia, hypotension, bradycardias, arrhythmias, cardiac arrest, seizures, allergic reactions, and paradoxical reactions ^{[6][8][9][11][12]}.

There is significant institutional variation in credentialing requirements for clinicians who provide procedural sedation ^[16]. Many institutions have developed formal training programs demonstrating improvements in the quality and safety of sedation services ^[17]-[20]. Participation in a formal training course is likely more effective in improving physician knowledge than self-directed learning ^[21]. Recommended core competencies can be found at http://www.pedsedation.org/resources/quality-safety/core-competencies. High-fidelity simulation team-based training may assist in training and maintaining the skills of health care providers (HCPs) to respond more effectively in emergency situations that could arise ^[22]-[24].

Patient selection

With respect to procedural sedation, children differ from adults in several ways. Paediatric patients are typically less able to cooperate, they often require a deeper level of sedation, and it is not uncommon for children to progress to a deeper level of sedation than intended ^[13][25]. Furthermore, paediatric patients, particularly infants, have a much smaller functional residual capacity and greater oxygen consumption. Critical hypoxia develops much more quickly during periods of apnea ^[26]. Anatomical differences (e.g., large occiput and tongue, floppy epiglottis, anterior and cephalad larynx, narrow subglottic airway) can pose challenges for clinicians who are inexperienced in managing paediatric airways. Paediatric patients are also prone to excitatory movements and adverse behavioural reactions (e.g., paradoxical responses to sedation, unpleasant recovery reactions) ^[6][27].

The pre-sedation evaluation should include a thorough history and focused physical examination (Table 1) to determine whether a patient is appropriate for procedural sedation by the non-anesthesiologist (i.e., American Society of Anesthesiologists ^[ASA] Class I and II, Table 2 ^[28]). Anesthesia consultation should be considered for patients who have symptoms of acute illness (e.g., upper respiratory tract infection), or active chronic conditions (e.g., recent asthma exacerbation), because these children are at increased risk for respiratory complications (e.g., bronchospasm, laryngospasm, oxygen desaturations) ^[29][30], and for infants less than 6 months of age, because they are at higher risk of adverse events ^[12]. Patients whose high risk of complications should prompt anesthesia consultation include:

• Those with features of a potentially difficult airway (e.g., history of difficult intubation, phenotypic features), respiratory disease (e.g., reduced pulmonary function tests), cardiac disease (e.g., pulmonary hypertension), 
• Preterm infants, who are at increased risk of post-anesthetic apneas until 60 weeks post-conceptual age ^[31],
• Obese patients, and
• Those with obstructive sleep apnea, who have an increased risk of airway obstruction following the administration of sedating medications ^[32][33].

Table 1. Key elements of the pre-sedation evaluation

Demographic data name, age, weight Details of procedure type, duration, urgency Past medical history acute medical conditions/current illnesses comorbid medical conditions review of systems previous sedations/anesthetics Allergies Medications Family history of anesthetic complications Social history Fasting status current or provide recommendations before procedure Physical examination baseline vital signs airway assessment for features of a difficult airway (e.g., craniofacial anomalies, abnormal neck mobility, small oral aperture or cavity, large tongue, neck masses, laryngeal and subglottic abnormalities) cardiopulmonary examination Other investigations as required Summary ASA physical status assessment sedation plan and rationale planned disposition Informed consent

ASA American Society of Anesthesiologists

 

Table 2. American Society of Anesthesiologists (ASA) Physical Status Classification System
	Definition	Examples*
ASA I	Healthy, normal child
ASA II	Child with mild systemic disease	Controlled asthma, controlled diabetes
ASA III	Child with severe systemic disease	Active wheezing, diabetes with complications, heart disease that limits activity
ASA IV	Child with severe systemic disease that is a constant threat to life	Status asthmaticus, severe bronchopulmonary dysplasia, sepsis
ASA V	Child who is moribund who is not expected to survive 24 h with or without an operative procedure	Severe traumatic brain injury, septic shock
* Modified from reference [28] to provide paediatric-specific examples ASA American Society of Anesthesiologists

Although recent studies have demonstrated no statistically significant association between pre-procedural fasting of any duration and any type of adverse event in children who undergo procedural sedation in the emergency department (ED) ^[34][35], ASA fasting guidelines recommend a minimum fasting period of 1 h for clear liquids, 4 h for human milk, and 6 h for infant formula, nonhuman milk, and light meals ^[36]. Children undergoing procedural sedation should be fasted according to institution-specific general anesthesia fasting guidelines and practices.

As part of the pre-sedation evaluation, the clinician should document findings of the history and physical examination, indications for sedation, the sedation plan, anticipated disposition following recovery, and informed consent (after providing information regarding medications, route of administration, expected response, anticipated duration of recovery, possible adverse effects, and risk for sedation failure). Development of institution-specific forms may facilitate complete and consistent documentation.

Emergency preparedness

Most adverse events are preventable, provided that patients have been appropriately selected, prepared, monitored, and managed in emergency situations ^[12]. Before commencing procedural sedation, the clinician should ensure the availability of:

1. Appropriate personnel
2. Monitoring equipment
3. Emergency equipment and rescue medications

1) Appropriate personnel

Procedural sedation should only occur in the presence of at least two HCPs, including a clinician skilled in procedural sedation and advanced airway management and resuscitation. One HCP must be dedicated to continuously monitoring the patient and responding to physiological changes. When the clinician responsible for the sedation is also performing the procedure, continuous patient monitoring and directed administration of medications should be delegated to another highly qualified HCP, such as another physician, a nurse practitioner, an anesthesia assistant, or a nurse with advanced resuscitation skills (e.g., several years of experience in ED, intensive care, or post-anesthetic recovery).

2) Monitoring equipment

Monitoring should include continuous pulse oximetry and intermittent noninvasive blood pressure monitoring every 5 minutes. The AAP and the ASA recommend the use of continuous 3-lead electrocardiography (ECG) and end-tidal carbon dioxide monitoring (i.e., capnography) for moderate sedation because this technique is superior to clinical monitoring alone ^[1][37]. Pulse oximetry is essential but insufficient because normal saturations may be maintained after the onset of inadequate ventilation. Hypoventilation can be masked by the maintenance of normal saturations. Although ECG electrodes allow for transthoracic impedance monitoring, chest wall movement may continue to be interpreted as “normal” during episodes of obstructive apnea or laryngospasm. Air flow is best assessed by auscultation. The ability to immediately detect ventilatory failure secondary to hypoventilation, apnea, upper airway obstruction, or laryngospasm allows for timely intervention and avoidance of progression to cardiac arrest ^[12]. Hospitals should ensure that the necessary equipment and HCP skills required to perform and interpret capnography are available for moderate to deep procedural sedations.

3) Emergency equipment and rescue medications

Regardless of the anticipated level of sedation, age- and size-appropriate emergency equipment (Table 3) and rescue medications (Table 4) should be immediately available. The clinician administering the sedation and HCPs who are assisting must ensure familiarity with the location and functioning of equipment and weight-based doses of rescue medications, including those required for cardiopulmonary resuscitation and reversal agents.

Table 3. Emergency equipment (SOAPME)

S = suction catheters and apparatus   O = oxygen supply and delivery equipment (e.g., flow meters, tubing, prongs)   A = airway equipment (e.g., face masks, nasopharyngeal/oropharyngeal airways, laryngoscope handles and blades, endotracheal tubes, stylets)   P = positive-pressure delivery system (i.e., bag-valve-mask ventilation)   M = monitors (e.g., pulse oximetry, end-tidal carbon dioxide, ECG leads, noninvasive blood pressure)   E = emergency cart with alternate airways (e.g., laryngeal mask airway), supplies for vascular access, and resuscitation drugs

 

Table 4. Rescue medications
	Dose range and route	Comments
Atropine	0.02 mg/kg IV (maximum 0.5 mg)	May repeat dose once (maximum total dose 1 mg for child; 3 mg for adolescent)
Epinephrine (0.1 mg/mL)	0.01 mg/kg IV (maximum 1 mg)	May repeat dose every 3 to 5 minutes
Flumazenil (benzodiazepine reversal)	0.01 mg/kg IV (maximum 0.2 mg)	May repeat every 1 minute to a maximum total cumulative dose of 0.05 mg/kg or 1 mg total, whichever is less   Contraindicated in patients with underlying seizure disorder
Naloxone (opioid reversal)	0.1 mg/kg IV (maximum 2 mg)	Dilute and titrate to effect   May repeat every 2 to 3 minutes   Contraindicated in patients with chronic opioid exposure
Succinylcholine	1 to 2 mg/kg IV (maximum 150 mg) 2 to 4 mg/kg IM	Essential rescue medication that should be drawn up for the treatment of severe laryngospasm and to facilitate rapid intubation, when needed.   Repeat doses increase risk for bradycardia

Medications for procedural sedation

Clinicians responsible for procedural sedation should have a thorough understanding of and experience with all medications being administered, including (but not limited to) mechanism of action, time of onset, peak response time, duration of action, and side effects. They should also be prepared to manage any adverse events resulting from the medications administered.

Medication choices should be based on patient characteristics, anticipated duration of the procedure, analgesic requirements, practitioner familiarity, and institutional availability and approval of use. General principles include matching to the type and duration of procedure (e.g., sedation versus sedation and analgesia; short- versus long-acting), and titration to desired effect. Although the use of multiple medications may increase risk for adverse events ^[11][38], combining medications has also been shown to provide better sedation, reduce total dose of medication used, and decrease recovery time ^[39][40].

Documentation, monitoring, and recovery

Documentation should include pre-sedation evaluation, informed consent, real-time recording of vital signs every 5 minutes during the sedation and every 15 minutes during the recovery period, medications administered (including dosage, route, and time), side effects, need for any unanticipated or emergency interventions (e.g., airway adjuncts, reversal agents or other rescue medications), adequacy of sedation (using a formal scoring system), and discharge instructions.

Although most serious adverse events occur within the first 25 minutes after the last dose of medication ^[41], post-sedation monitoring should continue until the patient has returned to baseline. Most reversal agents have a shorter half-life than their respective sedative agents. Patients who receive reversal agents should be monitored to ensure that sedation and cardiorespiratory depression do not recur once the antagonist effect has worn off.

Hospitalization for overnight observation should be considered for all patients who require emergency interventions.

Adverse events and quality assurance

The most common adverse events associated with procedural sedation involve airway obstruction or significant respiratory depression ^[12]. Although hemodynamic instability and cardiovascular collapse can occur, these events are often secondary to unrecognized and/or untreated respiratory compromise, and occur more frequently when procedural sedation is undertaken outside the hospital setting ^[12]. The vast majority of adverse events can be prevented when sedation is performed in hospitals adhering to guidelines ^[9][42].

Procedural sedation should only be performed within the context of a hospital program that participates in quality assurance through the reporting, monitoring, and review of adverse events. Unanticipated events, including the use of airway adjuncts, reversal agents or other rescue medications, must be clearly documented, and these cases should be reviewed as part of a quality assurance program. A template for the development of such policies and procedures at the institutional level can be found at http://www.pedsedation.org/resources/quality-safety/sedpolicy/.

Recommendations

Procedural sedation should only be performed in hospitals that can provide the following:

• Immediate availability of a clinician with advanced airway skills and competent in resuscitation and stabilization of the critically ill paediatric patient.
• An additional health care provider (HCP) to assist the clinician administering sedation. If the clinician is also performing the procedure and delegating continuous monitoring and directed administration of medications, the assistant must be a highly qualified HCP (e.g., another physician, nurse practitioner, anesthesia assistant, or a nurse with advanced resuscitation skills).
• Continuous physiologic monitoring with pulse oximetry and non-invasive blood pressure measurements. ECG and end-tidal capnography should be available when using intravenous (IV) sedation.
• Immediate availability of emergency equipment and rescue medications.
• Adequate post-sedation monitoring capabilities, including overnight admission if necessary.

HCPs considering procedural sedation must ensure that:

• The paediatric patient is an appropriate candidate (i.e., ASA Class I or II) based on a thorough history and focused physical examination.
• The patient is fasted in accordance with institutional guidelines.
•  Consenting decision makers and assenting patients are informed of the indications for, alternatives to, and risks and benefits of, procedural sedation. Informed consent for the sedation itself is required.
• Referral to anesthesia occurs when these criteria cannot be met or an increased level of complexity is predicted.

Clinicians providing procedural sedation services should be:

• Appropriately credentialed and participate in maintenance of skills activities.
• Fully cognizant of the indications, contraindications, and adverse effects of administered medications and experienced with their use.
• Prepared to manage patients at any depth of sedation.
• Competent in resuscitation and stabilization of the critically ill paediatric patient.

Hospitals should develop institutional policies and procedures for procedural sedation that include:

• Documentation of pre-sedation evaluation, informed consent, vital signs, medications administered, response to sedation, and unanticipated or emergency interventions.
• A checklist of immediately available emergency equipment and rescue medications.
• A process for reporting, monitoring, and reviewing adverse events.

Acknowledgements

This position statement was reviewed by the Community Paediatrics Committee and the Paediatric Emergency Medicine and Hospital Paediatric Section Executives of the Canadian Paediatric Society.

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CANADIAN PAEDIATRIC SOCIETY ACUTE CARE COMMITTEE

Members: Carolyn Beck MD, Kevin Chan MD (Chair), Kimberly Dow MD (Board Representative), Karen Gripp MD, Kristina Krmpotic MD, Marie-Pier Lirette MD (Resident Member), Evelyne D. Trottier MD
Liaisons: Laurel Chauvin-Kimoff MD (Past Chair 2012-2019), CPS Paediatric Emergency Medicine Section; Sidd Thakore MD, CPS Hospital Paediatrics Section

CANADIAN PAEDIATRIC SOCIETY DRUG THERAPY AND HAZARDOUS SUBSTANCES COMMITTEE

Members: Shinya Ito MD, Geert ‘t Jong MD (Chair), Jean-François Turcotte MD (Board Representative), Sunita Vohra MD
Liaisons: Michael J. Rieder MD, Canadian Society of Pharmacology and Therapeutics
Principal authors: Kristina Krmpotic MD, MSc, Michael J. Rieder MD, David Rosen MD

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References

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Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.