Pediatric sedation - Clinical Tree

Introduction

Sedation of children for tests and procedures inside and outside the operating room remains a critical part of the role anesthesiologists play in providing compassionate and effective care for children. Unlike other areas of anesthesia practice, in pediatric procedural sedation medical specialists (other than anesthesiologists) also provide sedation to children. This is driven largely by the workforce reality that more children will require sedation for procedures than can be cared for solely by anesthesiologists. It is also the case that, in some straightforward cases, other providers may offer a lower cost option for providing this care while offering good safety and effectiveness in their care. Thus anesthesiologists will not only sedate/anesthetize children for tests and minor procedures but they will also continue to be involved in the oversight of sedation by other specialists. Often, there is no clear separation between cases that can and should be performed only by anesthesiologists versus those that are appropriately accomplished by other specialists. Regardless of this uncertainty, well-established guidelines and successful practice strategies exist and should be modeled when considering this area of clinical care. This chapter focuses on established sedation guidelines and concepts regarding clinical pediatric sedation as well as a review of sedation strategies that may apply to any provider of sedation.

Guidelines for sedation practice

Because sedation of children for procedures is practiced by a variety of medical specialists in a number of clinical settings, a number of organizations have published guidelines regarding this care. In spite of their different origins, the common elements outnumber the differences by a wide margin.

Guidelines for sedation have been published under the term guidelines but also may be called practice advisories or statements on the topic of sedation. Some guidelines are evidence based, using strict criteria for classification of the reliability statements made. Others are based on the authors’ opinions, with reference to important literature. In the final analysis, all sedation guidelines rely (to a large extent) on expert consensus because there is not a robust evidence base for most of the concepts that are put forward in sedation of children.

Centers for medicare & medicaid recommendations

Effective December 2, 2011, the Centers for Medicare & Medicaid Services (CMS) issued guidelines defining those qualified to administer deep sedation and oversee sedation (see Revised Appendix A in “Interpretive Guidelines for Hospitals” at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R74SOMA.pdf ).

These guidelines represented a fundamental restructuring of sedation in many hospitals, placing all deep sedation and anesthesia services under the administrative direction of one individual in each institution where these services are provided. They noted that this individual would logically be the chair of anesthesiology, but it could be another qualified physician. They require that the institution have defined policies for the provision of anesthesiology services and the clinical criteria that distinguish anesthesia from analgesia. They require that policies must follow nationally recognized guidelines and can include guidelines from a number of specialty societies. The CMS statement considers two large categories of care: the first includes topical anesthetics, minimal sedation, and moderate sedation; the second includes general anesthesia, regional anesthesia, and monitored anesthesia care including deep sedation ( Table 44.1 ). In the case of minimal sedation and local anesthesia, hospitals are given some latitude to determine who provides this care as long as it is consistent with applicable state recommendations on scope of care. With regard to deep sedation and anesthesia, registered nurses may not provide this level of sedation; a qualified anesthesiologist, an MD/DO (other than an anesthesiologist), a licensed dentist or oral surgeon, or a certified registered nurse anesthetist or anesthesia assistant working under the direction of an anesthesiologist may provide this care.

TABLE 44.1

Levels of Sedation

Level	Description of Level
Minimal sedation	State in which protective reflexes are maintained; retains the patient’s ability to maintain a patent airway independently and continuously; permits appropriate patient response to physical stimulation or verbal commands, such as “open your eyes.” Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are not affected.
Moderate sedation/analgesia	Patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
Deep sedation	Patient is not easily aroused. May be accompanied by partial or complete loss of protective reflexes; includes the inability to maintain a patent airway independently and respond purposefully to physical stimulation or verbal command. Patient may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
General anesthesia	Patient cannot be aroused, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

The joint commission

Issues relating to sedation in general and pediatric sedation in particular are found in a variety of locations in The Joint Commission (TJC) Handbook and website ( http://www.jointcommission.org ). TJC (then known as the Joint Commission for Accreditation of Healthcare Organizations) published the Comprehensive Accreditation Manual for Hospitals in 2004, with regular updates thereafter, to set the standards for sedation and anesthesia care for patients in any setting. These standards detail requirements for room setup, documentation, patient monitoring both intra- and postprocedure, discharge criteria, credentialing and privileging of providers, and quality improvement. A helpful review of the standards can be found at http://www.compass-clinical.com/reducing-variability-in-your-moderate-sedation-program-is-key-to-patient-safety .

TJC recommendations are important when considering the credentialing and privileging of sedation providers in the United States. They require that hospitals define the scope of practice for practitioners. When reading and interpreting these documents, it is important to distinguish the terms credentialing and privileging. Credentialing is the process whereby designated hospital appointees assure that physicians who work in the hospital have the appropriate education, training, and licensure to practice in the institution. Privileging specifically gives permission to staff to provide care in various clinical settings or perform particular procedures in a given institution. With regard to sedation privileging, each healthcare institution is mandated by TJC to approve a plan to provide sedation and anesthesia care. Although the requirements for training are not specifically outlined, each institution must outline the criteria for determining which practitioners are qualified to provide the service. The TJC requires that individuals undergo ongoing professional practice evaluation and that their competence is assessed and documented once every 3 years or more (as required by the organization). The TJC standards also mandate an appropriate consent for sedation and outline the need for a history and physical within 30 days of the sedation and procedure. Furthermore, they require reassessment immediately prior to the sedation, a timeout prior to any procedure, and monitoring of the patient’s oxygenation, ventilation, and circulation as well as any sedation medication events. Finally, the TJC recommends monitoring during the recovery period, including a postprocedure note, discharge order, and discharge education.

American society of anesthesiologists policies and recommendations

The American Society of Anesthesiologists (ASA) has many statements and guidelines that address sedation by non–anesthesia providers. All statements and other documents are available at https://www.asahq.org/standards-and-guidelines . , published in 1996 and revised regularly, is the most widely quoted document concerning sedation from the ASA. It covers patient selection and preparation, intra- and postprocedure monitoring, discharge evaluation, and various medications that could be used.

The Statement on Granting Privileges to Non-Anesthesiologist Physicians for Personally Administering or Supervising Deep Sedation (2017; visit https://www.asahq.org/standards-and-guidelines/statement-on-granting-privileges-to-nonanesthesiologist-physicians-for-personally-administering-or-supervising-deep-sedation ) was originally approved in 2006. This document primarily concerns itself with the appropriate training required for the provision of deep sedation. It recommends that the physician or dentist administering deep sedation should have proven competency to bag-valve-mask ventilate, insert an oropharyngeal airway, place a laryngeal mask airway, and perform an endotracheal intubation. The advisory states that training for these individuals should include a minimum of 35 patients, inclusive of simulator experience. Practitioners should be familiar with the use and interpretation of capnography. Finally, this document recommends that deep sedation of children requires Pediatric Advanced Life Support (PALS) and Advanced Cardiac Life Supports (ACLS) certification as well as separate education, training, and credentialing in sedation. The authors note that “because of the significant risk that patients who receive deep sedation may enter a state of general anesthesia, privileges for deep sedation should be granted only to non-anesthesiologist physicians who are qualified and trained in the medical practice of deep sedation and the recognition of and rescue from general anesthesia.” This publication discourages specialists who are not anesthesiologists from delegating or supervising the administration of sedation by individuals who are not so qualified.

American academy of pediatrics/American academy of pediatric dentistry guidelines

The American Academy of Pediatrics/American Academy of Pediatric Dentistry (AAP/AAPD) guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures are the most widely referenced guidelines for pediatric sedation ( ). Much of their lexicon and recommendations have been adopted by TJC and regulatory bodies in the North America, and are echoed in society recommendations from Europe, Australia, and New Zealand. For more information, visit http://www.anzca.edu.au/getattachment/Resources/Professional-documents/ps09-2014-guidelines-on-sedation-and-or-analgesia-for-diagnostic-and-interventional-medical-dental-or-surgical-procedures .

The first guideline for pediatric sedation—Guidelines for the Elective Use of Conscious Sedation, Deep Sedation, and General Anesthesia in Pediatric Patients—was written in 1986 as a collaboration between the AAP, the AAPD, and the ASA with the intention of improving sedation safety through the adaptation of concepts that had been pioneered in anesthesiology ( ). It emphasized standardization of informed consent, NPO intervals, charting of vital signs, availability of appropriate equipment, appropriate monitoring, basic life-support skills, and proper recovery and discharge procedures. The authors advocated for an independent observer whose only responsibility was to monitor the patient. More recent versions of the guideline have codified a description of sedation levels: “minimal sedation, moderate sedation, deep sedation, and anesthesia.” These sedation levels remain the accepted description of sedation states ( Table 44.1 ).

In the most current iteration of the AAP sedation guidelines ( ), the authors emphasize that sedation is a continuum rather than clearly distinct states, and the sedation provider must be capable of rescuing a patient for a level of sedation one step deeper than intended. The authors contend that deep sedation requires special expertise and personnel resources. There must be two people present with appropriate training and up-to-date certification in patient rescue (i.e. PALS/Advanced Paediatric Life Support). One person’s sole responsibility is to constantly observe the patient’s vital signs, airway patency, and adequacy of ventilation, and to either administer drugs or direct their administration.

It should be noted that the requirement for a trained independent observer for a deeply sedated patient has been endorsed by numerous US and international organizations involved in the sedation of children ( ). For more information, visit http://www.pedsanesthesia.org/joint-statement-on-pediatric-dental-sedation/ . The exception to this model of sedation monitoring is to be found in the offices of oromaxillofacial surgeons and some dentists, where a single-operator model is employed. In this model, a single anesthesia permit holder administers sedation and simultaneously performs a dental or surgical procedure, often with a dental assistant for support. This practice has been associated with excess patient morbidity and mortality ( ).

American college of emergency physicians guidelines

Since 1998, the American College of Emergency Physicians (ACEP) has regularly published and issued revisions to their Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department ( ), including the statement titled Unscheduled Procedural Sedation: A Multidisciplinary Consensus Practice Guideline ( ). These guidelines are not specific to children, but they include recommendations concerning pediatric patients. They recognize that sedation is a continuum and maintain that practitioners should possess competence in cardiovascular resuscitation and airway management that should be sufficient to rescue a patient who has achieved general anesthesia if that is the level of sedation achieved. The ACEP considers these skills, including the administration of deep sedation, to be a fundamental part of the emergency medicine training curriculum for all board-certified emergency physicians.

The statement titled Unscheduled Procedural Sedation: A Multidisciplinary Consensus Practice Guideline ( ) is largely congruent with the statements released by other societies. The ACEP guideline has a more permissive approach to NPO status for sedation compared with the ASA NPO recommendations. NPO status will be discussed in more depth later in this chapter.

Clinical sedation practice

Goals of sedation

The goals of procedural sedation are similar to those of anesthesia for surgical procedures. The major goals are as follows:

1.
Eliminating or minimizing pain and anxiety
2.
Avoiding emotional trauma
3.
Controlling patient movement (behavior) to ensure adequacy of the test and/or a successful result
4.
Assuring patient safety by maintaining, respiratory, cardiovascular, and autonomic stability
5.
Returning the child to their normal state of function when the sedation or anesthesia is completed

Presedation phase

A presedation assessment is a critical step in identifying patients at high risk for adverse sedation events. Several key facts are important to bear in mind when considering patient risk during a sedation encounter:

1.
The vast majority of adverse outcomes during pediatric procedural sedation are primarily respiratory in nature ( ).
2.
In general, the greater the depth of sedation, the greater the risk for complications ( ).
3.
A common factor in adverse events with poor outcomes is that they occur when sedation guidelines are not followed, such as providing sedation with insufficient monitoring or inadequate rescue capability ( ; ).
4.
Drug-related adverse sedation events are usually related to dosage errors or the inappropriate combination of drugs more than to a specific drug class or drug route of administration ( ).
5.
Severity of illness and patient-specific factors are associated with adverse sedation events. ASA III or IV status patients have a higher rate for adverse events ( ; ). Specific conditions that affect adequacy of respiration or airway patency must be identified and addressed prior to beginning a sedation encounter ( ; ).
6.
Young age of a patient is associated with higher risk during procedural sedation ( ; ; ), as is obesity ( ).

In order to minimize risk (and optimize performance) during procedural sedation, the provider must appreciate all aspects of the sedation encounter associated with the patient, the procedure, and the provider.

Patient-related factors

General history

The general health status of each patient undergoing sedation must be evaluated. As per requirements from TJC, presedation documentation should include the chart review, positive findings, and a sedation management plan. If the clinical scenario precludes acquiring complete information before sedation, the health evaluation should be obtained as soon as feasible.

Allergies

It is imperative that a good drug allergy history be elicited prior to providing sedation. Type 1 IgE-mediated allergic reactions to commonly used sedation medications are extremely rare ( ). More likely, a variety of reactions may be interpreted as an allergy. A history of the type of reaction that occurred should be obtained. Reactions such as crying or local redness at the site of injection may be interpreted as a systemic allergy and should be considered on a case-by-case basis.

The potential for association of food allergy with an adverse reaction to propofol has been of concern in the sedation and anesthesia community, as propofol is dispensed in a lipid emulsion that contains either egg or soy components, depending on the manufacturer. Numerous studies have not supported a connection between food allergy and risk with propofol use, although severe atopy might be taken as a relative contraindication to propofol administration ( ).

Current medications

Evaluation of current medications will aid in avoiding obvious adverse interactions with sedatives. For instance, dexmedetomidine administration to a patient on digoxin or beta blockers can lead to extreme bradycardia ( ). In addition, sedation providers must appreciate that the patient who is on chronic opioid or benzodiazepine therapy will likely need increased doses of these medications to obtain a desired effect due to tolerance ( ). (Patients taking antiepileptic medications will have varying interactions with sedative medications, with some resistance to opioids and benzodiazepines and possibly an increased sensitivity to the effects of propofol [ ]).

It is important to determine whether a patient is taking over-the-counter medications, herbal, homeopathic preparations ( ), or recreational drugs, as many of these could have interactions with sedative and anesthetic medications. Unfortunately, in many cases these interactions are incompletely characterized ( ), and it may be prudent to recommend that patients not take these in the period preceding sedation or anesthesia. Marijuana has been legalized in 28 US states as of 2018, which has resulted in more patients, even in the pediatric population, using it recreationally or with therapeutic intent. Its interaction with sedative and anesthetic medications is still being characterized, but there is some indication that regular users of marijuana require higher doses of sedative medications than nonusers ( ).

Sedation/anesthesia history

Many children presenting for procedural sedation will not be naïve to the process. These patients will have diagnoses that require repeated frightening or painful interventions, and it is incumbent on the professionals providing sedation or anesthesia to make the experience as stress-free as possible so that additional psychological trauma is not imposed on the patient. Review of prior sedations or anesthetics is imperative for these patients, both to know what works and what does not. A review of prior sedation experiences is particularly important as well for patients with developmental delays or autism for whom specific routines around sedation are often developed and would not be readily apparent to the sedation provider ( ). A patient-centered approach, ideally incorporating the assistance of child life specialists, will pay dividends both emotionally and financially, reducing the need for sedation at all for some patients ( ). A thorough exploration of the child’s previous sedation experiences may be the single most helpful portion of the presedation evaluation. In addition to all of the information mentioned earlier, a history of multiple failed sedation attempts may indicate the need not to repeat previous failures and to opt for general anesthesia.

Adverse reactions to past sedations/anesthetics

Paradoxical reactions to sedative medications are common and occur in 3% to 29.3% of pediatric patients ( ; ). Chloral hydrate or midazolam can elicit crying and combative behavior rather than sedation. This reaction can be age and dose related. Children who have the reaction once are more likely to experience it again, so is critically important to elicit this information prior to repeating a failed strategy ( ) .

Nausea and vomiting may result from sedation, particularly with ketamine ( ; ). Treatment with 5HT3 receptor inhibitors or dexamethasone may decrease the incidence of these symptoms ( ).

Emergence agitation (EA) has been described during the recovery phase after sedation, particularly when a barbiturate or ketamine has been administered ( ). In these cases, patients may be delirious and combative for a period of 10 to 30 minutes (rarely longer) on awakening from sedation. Children who have had EA in the past are more likely to experience it with future sedation encounters. Parents should be informed about this risk. The incidence of emergence agitation can be attenuated with propofol or dexmedetomidine, if not contraindicated ( ; ).

Airway issues

As part of the presedation evaluation, specific abnormalities of the airway should be noted. These issues can be divided into two general categories: (1) the difficult functional airway and (2) the difficult anatomic airway ( ).

The difficult functional airway subgroup refers to those patients who are expected to have difficulty simply breathing air through their natural airway when sedated. Children in this category include those with severe sleep apnea, obesity, recurrent croup, markedly enlarged tonsils, or those with congenital anomalies that make sleeping in the supine position difficult or impossible ( ). Interestingly, a higher Mallampati score may not correlate with sedation adverse events but may predict the need for airway repositioning during sedation ( ). Because most sedation cases are accomplished without the assistance of an artificial airway adjunct, it is particularly important to know if a patient has major issues with snoring at night associated with apnea or prolonged pauses in respiration. Although polysomnography remains the gold standard for evaluation of sleep-disordered breathing, it may not always be available, and alternative evaluation methods may be employed such as nighttime pulse oximetry, drug-induced sleep endoscopy, and urinary biomarkers ( ).

The difficult anatomic airway subgroup includes patients in whom visualization of the airway with direct laryngoscopy is difficult. Any syndrome that results in an unusual facial appearance should be carefully noted, as they may also be associated with an airway that is difficult to visualize should emergent intubation become necessary ( ).

Recent acute illness

When assessing sedation risk, children with upper respiratory tract infection (URTI), fever, and other acute illnesses should be considered differently from those who are well. Studies of children undergoing anesthesia during a limited URTI have shown an increase in minor airway issues but no evidence of severe morbidity or mortality ( ; ). The incidence of airway-related issues is further increased if these children live with individuals who smoke ( ). The largest study to date is from the Pediatric Sedation Research Consortium review of >80,000 patients ( ). In this study, adverse airway events occurred with increasing frequency from no URI to recent URI, to current URI with thin and/or clear secretions, and then to current URI with thick and/or green secretions, increasing the chances of an adverse airway event from 6% in patients with no URI to 22% in patients with current URI and thick secretions. With this in mind, children with mild or moderate nasal discharge or those with minimal cough symptoms should be considered for sedation on a case-by-case basis. For cases such as MRI scans, where slight movement such as coughing will render the study unreadable, rescheduling or changing strategies to control the airway may be prudent. In addition, if sedation is provided for those with a URTI, the postprocedural observation may need to be extended ( ). Children with new-onset croup, systemic symptoms, or lower respiratory tract symptoms should have their elective sedation postponed.

NPO status

The question of how long a child should fast prior to elective sedation or anesthesia is currently the subject of much study, with recommendations worldwide in a state of flux. Current ASA NPO recommendations ( Table 44.2 ) are followed by the majority of sedation guidelines in the United States. The recommendations assume that airway-protective reflexes could be lost at any time during moderate or deep sedation and therefore mirror the recommendations made for patients undergoing anesthesia. The guidelines suggest that the NPO status must be weighed against the urgency of a procedure when deciding the timing of a procedure. Data suggest that NPO status may be less of an issue than previously thought ( ). In a report on major adverse events (aspiration, death, cardiac arrest, and unplanned admission) from the Pediatric Sedation Research Consortium database involving over 240,000 sedations/anesthetics, aspiration was less than 1 per 10,000, whereas other major adverse events were between 5 and 6 per 10,000. Of note, the patient’s NPO status was not an independent predictor of aspiration or of other major adverse events. Based on data such as this, a number of international anesthesia societies have altered their NPO requirements, decreasing the length of fasting required after ingestion of clear liquids from 2 hours to 1 hour ( ; ).

TABLE 44.2

American Society for Anesthesiologists NPO Guidelines

Food	Hours of Fasting Required
Clear liquids	2
Breast milk	4
Formula or light meal (no fat)	6
Fried or fatty foods, meat	8 or more

Policy statements from the American College of Emergency Physicians discuss fasting prior to sedation in the emergency setting ( ). Their conclusion is that no consideration of fasting time is necessary before performing sedation in the emergency setting, although they do note that it is possible there are subgroups of patients who may be at higher risk of aspiration.

The lack of definitive data on risk for aspiration related to NPO status during sedated procedures results in the current discrepancy in recommendations from the ASA, international anesthesia societies, and ACEP. For now, the most appropriate interpretation of these (collected) recommendations would conclude that the requirement for NPO should be considered with respect to the risk of delaying a procedure, the nature of the pathology that a given patient presents, and the nature of the enteral intake. For example, an otherwise well 4-year-old presenting for a CT scan may have eaten one cracker 3 hours ago. The risk profile of this patient could reasonably be assumed to be different than that of a 4-year-old who ate a complete meal 1 hour ago and is now scheduled for bronchoscopy. Neither child meets NPO criteria, but the calculation of risk versus benefit would be radically different for these two individuals.

Sedation-specific review of systems

Developmental issues

The neurodevelopmental status of the child is critical to consider when planning sedation for a procedure. The technique of sedation may change greatly for any child who is severely delayed and/or autistic ( ). Children with autism will present on a spectrum from easily calmed and engaged to demonstrating severe and impenetrable fears of the healthcare environment and the overwhelming stimuli therein. Every effort should be made to elicit the history of previous efforts at calming the child and obtaining some level of cooperation. In many of these cases, an individual plan of care and extra time or staff allotted to the patient will be beneficial ( ). Interventions may include counseling, teaching, instructing family members either in person or by phone, visiting the sedation/radiology unit, simulating mock inductions, involving play therapy, and administering premedication. Other distraction techniques including music, DVD entertainment, video games, toys, and hypnotherapy should also be considered ( ).

In some cases, premedication by the oral, intranasal, or intramuscular route may be of assistance ( ; ; ). Although numerous options exist, it should be noted that comparison studies suggest that intranasal dexmedetomidine is emerging as a popular option for its favorable sedation profile and few unpleasant side effects ( ) (see Box 44.1 ).

BOX 44.1

Some Common Premedication Options

Intranasal dexmedetomidine: 2.5 mcg/kg (Ghai et al. 2017)
Intramuscular dexmedetomidine: 1 to 3 mcg (Mason et al. 2012)
Oral midazolam: 0.5 to 0.75 mg/kg (Cote et al. 2002)
Intranasal midazolam: 0.2 to 0.4 mg/kg (Manoj et al. 2017; Mahdavi et al. 2018)
Oral ketamine: 6 to 8 mg/kg
Intramuscular ketamine: 4 to 5 mg/kg (Khanduri 1999)
Combined intranasal dexmedetomidine: 2 mcg/kg with oral ketamine 3 mg/kg (Qiao et al. 2017)

Regardless of the exact approach, the most important aspect of managing combative or uncooperative children is the presence of a coordinated plan among the caregivers that respects the wishes of the family and the desires and safety of the child. For example, some families and patients might prefer an intramuscular administration of medication over an intranasal route.

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