Sedation for Diagnostic and Therapeutic Procedures Outside the Operating Room

The Evolution of Pediatric Sedation and the Anesthesiologist's Role

Perhaps more than ever, the care of children in the hospital setting requires the provision of sedation in a timely and effective manner. Many children who require an imaging procedure or invasive test before surgery will not tolerate the procedures without sedation. In addition, children with neurologic, gastroenterologic, or oncologic (medical) illness require repeated tests and procedures for a single course of treatment that may be uncomfortable or invasive. In some, sedation is required because of age, anxiety, or developmental delay. A responsive and accommodating sedation service that helps accomplish these procedures in a safe, efficient, and effective manner is an indispensable component of a functional hospital or health system.

The provision of sedation care for children undergoing tests and procedures outside the operating room continues to evolve. Forty years ago, physical restraint without medications was the preferred method to achieve these objectives in children, but today, that approach is completely eschewed and supplanted with sedation in an atmosphere of respect and safety that is on par with the quality of care provided to children undergoing surgery. At the same time, we must recognize that the sheer numbers of children who require sedation exceed the capacity of pediatric anesthesiologists to provide all of this care; partnership with other types of physicians and nurses who are capable and willing to deliver pediatric procedural sedation is required. Furthermore, economic pressures in medicine demand systems that optimize efficiency, throughput, and effectiveness of the care provided. While anesthesiologists may find the practice of sedation only moderately challenging, understanding the environment, guidelines, and organizational issues involving sedation practice for ourselves and our partners is critical if we are to improve the overall delivery of this care to children globally.

Sedation/analgesia for painful procedures performed outside the operating room (OR; e.g., bone marrow aspiration, lumbar puncture, repair of minor surgical wounds, insertion of arterial or venous catheters, burn dressing changes, fracture reduction, bronchoscopy, and endoscopy) requires the same attention to detail as for procedures performed in the OR because the level of sedation needed is usually deep sedation or general anesthesia, particularly for children 6 years of age and younger, as well as for those at any age with developmental delay. Children undergoing diagnostic studies (e.g., computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET], electroencephalography [EEG], electromyography) and those who require high doses of ionizing radiation require deep levels of sedation or general anesthesia because they must remain absolutely motionless (sometimes with breath-holding). Given these requirements, a coordinated team approach is required to provide safe, optimal conditions for the procedure.

The need for sedation services goes beyond the very young and developmentally challenged patients usually associated with this requirement. Older children and adolescents without developmental delay may also require sedation to undergo a procedure/investigation in a confined space (e.g., MRI scans) because of claustrophobia. Other procedures, such as sexual abuse examinations or urinary catheterization, are more emotionally disturbing than painful, but they still require sedation to control anxiety and fear that can ultimately lead to long-term emotional/psychological harm if they were performed without anxiolytics. Furthermore, a child's emotional state may be worsened by parental anxiety, separation from parents, and the pain (or anticipation of pain) from the procedure (see Chapter 3 ). Distraction, guided imagery, and the use of videos and music have proven beneficial in this respect, although they may be insufficient to provide the conditions needed to complete all procedures in their entirety.

The pharmacologic armamentarium for sedation for diagnostic and therapeutic procedures has greatly expanded over the past 10 years to include potent sedative hypnotics, opioids, and dissociative agents. The determination as to which physicians can use these medications and what qualifications are needed to provide deep sedation/anesthesia has been the subject of some debate. Although the final determination of how this care will be provided remains contentious, the clear trend is toward liberalization of the use of drugs such as propofol, dexmedetomidine, remifentanil, and ketamine. One driving force for this change is the demand for efficient sedation and analgesia outside the OR. Pressure comes from many sources, including hospital administrators, insurance companies, medical specialists, and families, because failures and missed appointments significantly increase hospital costs and frustrate parents. Failed sedations for diagnostic or therapeutic procedures are no longer accepted as part of the sedation process; the use of more potent medications decreases the chance of inadequate sedation. All of these factors have led to the “professionalization” of pediatric sedation with the creation of pediatric sedation services, many of which are led by pediatricians, hospitalists, emergency medicine physicians, intensivists, and dentists. Examples of the changing landscape of sedation abound. A 2005 survey of pediatric sedation practice in 116 children's hospitals in the United States and Canada reported that anesthesiologists exclusively provided the sedation in only 26% of institutions. Similarly, the Pediatric Sedation Research Consortium (PRSC), a collaborative of hospitals heavily committed to improving pediatric sedation, noted that most sedation in the participating institutions (over 100,000 encounters) was delivered by organized sedation services of which anesthesiologists were involved in only 19%. When specifically evaluating the use of propofol in a cohort of 50,000 encounters, the PRSC noted that anesthesiologists were involved only 10% of the time. Despite this changing landscape of sedation, anesthesiologists are still charged by the federal government and the Joint Commission of Hospital Accreditation (JCAHO) in the United States to exercise oversight of sedation practices. To provide effective leadership, anesthesiologists must have a full appreciation of the issues involved in this dynamic area of practice. This chapter focuses on the current definitions of sedation for diagnostic and therapeutic procedures and the goals, risks, and guidelines for creation of safe conditions for children who require sedation for procedures outside the OR.

Sedation Depth

The Concept of Levels of Sedation

Several organizations have defined levels of sedation. The definitions of the American Academy of Pediatrics (AAP), the American Society of Anesthesiologists (ASA), JCAHO, and the American Academy of Pediatric Dentistry (AAPD) are the most frequently cited and agreed-upon position statements. These organizations defined sedation and analgesia for procedures as a continuum, including minimal sedation (anxiolysis), moderate sedation, deep sedation, and general anesthesia ( Fig. 48.1 ). All of these definitions are created with the appreciation that a child's depth of sedation may easily pass from one level to another and without easily identifiable signs of any change in condition. The definitions that follow are taken from JCAHO (2010) and are in agreement with the current AAP, AAPD, and ASA definitions :

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  Minimal sedation (anxiolysis): A drug-induced state during which patients respond to verbal commands. Although cognitive function and coordination may be impaired, cardiorespiratory functions are unaffected ( Video 48.1 ).

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  Moderate sedation (previously called “conscious sedation” or sedation/analgesia): A drug-induced depression of consciousness during which patients respond 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 ( Video 48.2 ).

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  Deep sedation: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimuli. ( Note: reflex withdrawal from a painful stimulus is not considered a purposeful response.) The ability to independently maintain respiratory homeostasis may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained ( Video 48.3 ).

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  General anesthesia: A drug-induced loss of consciousness during which patients are not arousable, even to painful stimuli. The ability to independently maintain respiratory homeostasis is often impaired. Patients often require assistance in maintaining a patent airway, and positive-pressure ventilation may be required because spontaneous ventilation is depressed or neuromuscular function is compromised. In addition, cardiovascular function may be impaired ( Video 48.4 ).

In clinical practice, procedures that require sedation in children may require deep sedation or general anesthesia for pain control (bone marrow biopsies) or movement control (MRI scans). They are rarely performed in a child under “moderate sedation.” Often moderate sedation is used inappropriately. It is not always easy to accurately describe the depth of sedation based on the child's responses to stimulation ( Fig. 48.2 ). In addition, there are problems with classifying responses when they occur. A child who is under moderate sedation should respond to touch or firm rubbing by an appropriate response, such as saying “ouch,” pushing your hand away, or pulling up the covers. The lack of a purposeful response is a sign that the child has progressed to a deeper sedation level and should lead to an escalation of monitoring and personnel. These differences are seldom appreciated and often lead to inappropriate care. Not surprisingly, an audit in a large pediatric hospital reported that their target level of either moderate or deep sedation was achieved in only 50% to 75% of patients; an awake state was achieved in 12% to 28% of the children, and general anesthesia was reached in 35% of children.

Sedation Scoring Systems

There are several validated scoring systems available for assessing sedated patients and grading their level of sedation. The Ramsay scale was described by Ramsay and colleagues in 1974 for the purpose of monitoring sedation with alphaxalone-alphadolone ( Table 48.1 ). It continues to be the most widely used scale for assessing and monitoring sedation in daily practice, as well as in clinical research. It spans the continuum of sedation but does not clearly separate purposeful from nonpurposeful responses. The Ramsey scale has been modified to more clearly coincide with the AAP and JCAHO guidelines ( Table 48.2 ). A score of 2 to 3 is anxiolysis, 4 to 5 is moderate sedation, 6 is deep sedation, and 7 to 8 is general anesthesia.

TABLE 48.1

Ramsay Scale

Level	Characteristics
1	Patient awake, anxious, agitated, or restless
2	Patient awake, cooperative, orientated, and tranquil
3	Patient drowsy, with response to commands
4	Patient asleep, brisk response to glabella tap or loud auditory stimulus
5	Patient asleep, sluggish response to stimulus
6	Patient has no response to firm nail-bed pressure or other noxious stimuli

TABLE 48.2

Modified Ramsay Sedation Scale

Score	Characteristics
1	Awake and alert, minimal or no cognitive impairment
2 a	Awake but tranquil, purposeful responses to verbal commands at conversation level
3 a	Appears asleep, purposeful responses to verbal commands at conversation level
4 b	Appears asleep, purposeful responses to verbal commands but at louder than usual conversation level or requiring light glabellar tap
5 b	Asleep, sluggish purposeful responses only to loud verbal commands or strong glabellar tap
6 c	Asleep, sluggish purposeful responses only to painful stimuli
7 d	Asleep, reflex withdrawal to painful stimuli only (no purposeful responses)
8 d	Unresponsive to external stimuli, including pain

a Minimal sedation.

b Moderate sedation.

c Deep sedation.

d General anesthesia.

The Observer's Assessment of Alertness/Sedation (OAA/S) scale is often cited as a scale for sedation. It is scored as follows: 1, no response to shaking; 2, responds to mild prodding; 3, responds to name called loudly; 4, lethargic response to name; and 5, readily responds to name. Its inability to clearly categorize deep levels of sedation and lack of a clear differentiation between purposeful and nonpurposeful responses limit its usefulness. A more useful clinical scale is the University of Michigan Sedation Scale (UMSS). It is an assessment tool that has been validated against the OAA/S scale and other scales of sedation ( Table 48.3 ). This scale has proven useful in children with significant learning impairment and delays. It separates patients into the sedation categories in line with those defined by the AAP, ASA, and JCAHO.

TABLE 48.3

University of Michigan Sedation Scale (UMSS)

Score	Characteristics
0	Awake and alert
1	Minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or sound
2	Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command
3	Deeply sedated: deep sleep, arousable only with significant physical stimulation
4	Unarousable

These responsiveness-based assessment tools require intermittently stimulating the child during the procedure to categorize patients. Unfortunately, poking or prodding the child to determine the depth of sedation defeats the purpose of sedation in many situations (e.g., infants, developmentally delayed children, or procedures requiring immobility). The authors of the guidelines that reference levels of sedation do not require frequent testing of sedation depth. Rather the responsiveness-based definitions are meant to provide a road map for safety that bases the level on the behavior of the patient in response to the procedure itself, with the understanding that a nonresponding child requires an increased level of vigilance. Unfortunately, infrequent testing leaves the sedation provider uncertain about the depth of sedation for significant periods of time during a test or intervention. Concerns regarding these types of assessment tools have led to the suggestion by some experts that there is a need to revise the sedation continuum and to use other monitoring parameters (such as physiologic status) to assess level of sedation. Still others have suggested that the use of an observational scale that simply codifies the “state” of the child at any time during the sedation/procedure is more useful than stimulation ( Table 48.4 ).

TABLE 48.4

The Dartmouth Operative Conditions Scale (DOCS)

Patient State	OBSERVED BEHAVIORS
Pain/Stress	(0)	(1)	(2)
	Eyes closed or calm expression	Grimace or frown	Crying, sobbing, screaming
Movement	(0)	(1)	(2)	(3)
	Still	Random little movement	Major purposeful movement	Thrashing, kicking, biting
Consciousness	(0)	(−1)	(−2)
	Eyes open	Ptosis, uncoordinated, “drowsy”	Eyes closed
Sedation Side Effects	(−1)	(−1)	(−1)	(−1)
	Sp o 2 < 92%	Noise with respiration	Respiratory pauses >10 seconds	BP decrease of > 50% from baseline

Patients are scored in four state categories at any one time during sedation for a procedure. The sum of the scores in all four categories is used to determine the DOCS score for any discrete point during a sedation encounter. BP, blood pressure; Sp o ₂ , oxygen saturation as measured by pulse oximetry.

For many years, the “holy grail” of sedation has been the noninvasive sedation monitor that would accurately detect and record the depth of sedation without stimulating the child or interfering with a procedure. Over the past 15 years, several monitors have been developed to assess the depth of sedation or anesthesia in a nonstimulating, continuous manner. Examples of the monitors include the BIS (bispectral index) monitor (Medtronic/Covidien, Minneapolis, MN); Narcotrend monitor (Narcotrend-Gruppe, Hannover, Germany); Danmeter AEP monitor/2 (Danmeter DK-5000, Odense C, Denmark); Patient State Monitor (PSA-4000, Pfizer/Hospira, Lake Forest, IL), the Cerebral State Monitor (Danmeter DK-5000, Odense C, Denmark); and the Entropy module (GE Healthcare/Datex-Ohmeda, Chicago, IL). While each of these has shown some level of utility, the most broadly applied (and thoroughly studied) of these is the BIS monitor, which uses a proprietary method for processing the EEG signal and converting that reading into a number between 0 and 100, which has been correlated with the depth of sedation. The BIS was derived from empirically estimating processed EEG parameters that best predicted OAA/S scale levels in adult volunteers receiving a wide variety of anesthetics, analgesics, and sedatives. BIS values in adults who are awake range from 95 to 100; when lightly to moderately sedated 70 to 95; when deeply sedated with a small probability of explicit recall 60 to 70; and general anesthesia, 40 to 60.

Attempts to correlate BIS values with the depth of sedation in children have been met with varying success, particularly when attempting to distinguish moderate from deep sedation. In part, these difficulties relate to two factors: (1) the algorithms have been validated only in adults, and (2) many of the anesthetics and drugs used to anesthetize and sedate children have not been adequately studied with the BIS monitor, even in adults. Other issues with the use of the BIS in children include the following:

• 1.

  BIS values are not age specific and are relatively inaccurate in children younger than 1 year of age.

• 2.

  BIS readings may differ from one side of the head to the other.

• 3.

  BIS readings are diminished in developmentally delayed children.

• 4.

  BIS is completely inaccurate with ketamine sedation because of ketamine-induced central excitation.

• 5.

  BIS readings are inaccurate during sedation with dexmedetomidine.

Finally, practical problems with the use of BIS-type monitoring include the following:

• 1.

  It is not feasible for many procedures, such as MRI scans.

• 2.

  BIS is not applicable for procedures involving the mouth and airway (endoscopy, dental, bronchoscopy), because the monitor creates artifacts or is in the way of the proceduralist.

• 3.

  Muscular activity around the head creates artifact. Overall, the lack of specificity for levels of sedation, low quality of BIS data, and the lack of information for different age groups or specific drugs preclude recommendation of the BIS for use in procedural sedation in children at this time.

Similar limitations exist for the other monitors of sedation/anesthesia depth. While they may be helpful in specific instances or clinical situations, their general use is not advised.

Sedation Depth Versus Sedation Risk

Sedation scales and sedation depth monitors attempt to quantify the depth of sedation but do not directly measure the “risk” of sedation. While the depth of sedation is defined by response to stimulation, the important assessment of the child is not the response to stimulation, but the ability to protect and maintain the airway . In fact, each sedative drug or a particular dose of a drug may provide pain relief but may also obstruct the airway or depress ventilation. For example, propofol is a potent, effective sedative that confers no analgesia but has marked effects on the airway tone and respiratory drive. Conversely, dexmedetomidine provides less intense sedation than propofol but modest pain relief with minimal depression of respiration and minimal compromise of airway morphology. In contrast, ketamine produces intense analgesia and decreases the responses to stimulation, but infrequently obstructs the airway or depresses respiratory effort even at very large doses ( Table 48.5 ).

TABLE 48.5

Examples of Sedative Drugs That Have Varying Effects on Response to Pain and Airway Protection

Response to Pain Does Not Predict Airway Maintenance All Drugs Are Different
	Response to Pain	Airway Maintenance
Fentanyl	↓↓	↓
Propofol	±	↓
Ketamine	↓	±
Dexmedetomidine	↓	+

↓↓, large decrease in response to pain or large effect on airway patency; ↓, some decrease in response to pain or some effect on airway patency; ±, minimal to no effect on response to pain or effect on airway patency; +, no effect on airway patency.

There are also aspects of the patient that affect risks for airway-related adverse events as much as sedation depth. For instance, a child with obstructive sleep apnea (OSA) or obesity is much more likely to obstruct his or her airway during deep sedation than one who does not have this comorbidity. A history of prematurity has been shown to increase the risks associated with sedation throughout childhood and adolescence. Furthermore, other comorbidities such as congenital heart disease, airway anomalies, lower respiratory tract disease, and upper respiratory tract infection increase the risk of general anesthesia, and one would expect that they would also increase the risk of sedation, although they have not been studied specifically in this regard. Similarly, the procedure itself can increase the risk for a child. A bronchoscopy or upper gastrointestinal endoscopy carries much greater risks of airway-related events than a noninvasive diagnostic test. The environment of the procedure can also increase risk. The MRI scanner (where the observer is remote from the airway during the scan and ferromagnetic objects are forbidden) is a significantly more difficult environment than one where the sedation provider can be situated at the airway and all monitors and rescue equipment are available (as per standard routine). In summary, when assessing the risk of sedation, one must consider the multidimensional aspects of sedation that include the planned level of sedation, existing comorbidities in the child, the procedure to be performed, and the environment in which the procedure will be performed.

The safety of sedation must also focus on appropriate discharge readiness and the subtle differences in recovery from sedation. Adverse events, including deaths, have occurred after premature discharge after procedural sedation. These events were most often associated with sedating medications with a prolonged duration of effect such as chloral hydrate ( Fig. 48.3 ). With this in mind, a simple “maintenance of wakefulness” score (infants had to stay awake for at least 15 to 20 consecutive minutes in a quiet environment before discharge) ensured that more than 90% of children had returned to baseline levels of consciousness, compared with only 55% of children assessed as “street ready” according to usual hospital discharge criteria.

Guidelines

With the definitions of depth of sedation in mind, multiple organizations have produced guidelines for the conduct of sedation in pediatric patients. The first sedation guideline was published in 1985 from the Committee on Hospital Practice and the Section on Anesthesiology of the AAP. The guideline emphasized systems issues pioneered in anesthesiology, such as the need for informed consent, appropriate fasting before sedation, frequent measurement and charting of vital signs, the availability of age- and size-appropriate equipment, the use of continuous physiologic monitoring (pulse oximetry), the need for basic life support skills, as well as proper recovery and discharge procedures. A 2002 amendment of these guidelines eliminated the use of the confusing term conscious sedation and replaced it with the term moderate sedation. The AAP's guideline was updated again in 2006. It unified the definitions of sedation depth used by the ASA and the JCAHO and emphasized further refinements of a systematic approach to sedation that included the following:

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  No administration of sedative medications without the safety net of medical supervision (i.e., no sedative medications given at home).

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  Careful presedation evaluation to include review of pertinent medical and surgical conditions.

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  Careful history for ingestion of nutraceuticals and other medications that may alter drug metabolism and prolong sedation.

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  Appropriate fasting guidelines for elective and urgent procedures. There should be a balance between the depth of sedation and the risk for those who are unable to fast because of the urgent nature of the procedure.

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  Focused airway examination with particular attention to anatomic airway abnormalities and enlarged tonsils.

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  Understanding the pharmacokinetic and pharmacodynamic effects of sedation medications and drug interactions.

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  Appropriate training and skills in airway management for sedation providers to allow for rescue. Deep sedation requires training in Pediatric Advanced Life Support (PALS).

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  Immediate availability of size- and age-appropriate airway, monitoring, and resuscitation equipment.

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  Appropriate emergency medications and reversal agents available for sedation in all cases.

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  Sufficient personnel to carry out the procedure and monitor the child.

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  Appropriate physiologic monitoring during and after the procedure; use of capnography is encouraged.

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  A “time-out” should be performed before sedation.

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  Recovery personnel, monitoring, and discharge criteria with return to baseline condition before discharge.

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  Continuous quality improvement to track common markers of potential safety issues, such as desaturation events, airway obstructions, laryngospasm, unplanned hospital admission, unsatisfactory sedation, and medication errors.

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  Use of simulators to practice management of rare adverse events.

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  Assume that all children younger than 6 years of age will be deeply sedated for painful procedures or those that are not painful but prolonged.

The most recent version of the AAP guidelines was published in 2016, in which the guidelines for sedation used by pediatric medical and dental practitioners were unified with the same language, the same definitions, and the same goals. The new version added clarifications regarding respiratory monitoring modalities, particularly that continuous capnometry is recommended for moderate sedation and required for deep sedation, provided updated information from the medical and dental literature, and suggested methods for further improvement in safety (incorporating checklists, human simulation training) and documentation. Other important changes included that the responsible practitioner for moderate sedation must have the skills to rescue a child with apnea, laryngospasm, airway obstruction, and perform successful bag-mask ventilation. The practitioner who practices deep sedation must have these same skills and be able to perform tracheal intubation and cardiopulmonary resuscitation. Additionally, the skilled observer for either moderate or deep sedation must be trained in PALS and be capable to assist with any emergency . Three decision trees that guide the management of airway obstruction, laryngospasm, and apnea were added.

This recent guideline further emphasized the following:

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  Patient Evaluation. Clinicians should be familiar with the sedation-related aspects of the patient's medical history. These include (1) abnormalities of major organ systems; (2) previous adverse effects with sedation and general anesthesia; (3) drug allergies, current medications, and drug interactions; (4) time and nature of oral intake; and (5) history of tobacco, alcohol, or substance abuse. A focused physical examination, including vital signs, auscultation of the heart and lungs, and evaluation of the airway, is recommended.

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  Preprocedural Preparation. Patients should be informed of and agree to sedation, including its risks, benefits, limitations, and alternatives. Sufficient time should elapse before a procedure to allow gastric emptying for elective procedures in healthy children as per the ASA guidelines: minimum fasting intervals of 2 hours after clear liquids, 4 hours after breast milk, 6 hours after infant formula, nonhuman milk, and a light meal (dry toast, tea without milk), and 8 hours after fatty food. If urgent, emergent, or other situations impair gastric emptying, the potential for pulmonary aspiration of gastric contents must be considered when determining the target level of sedation, delay of the procedure/investigation, or the need to secure the airway (e.g., tracheal intubation).

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  Monitoring Level of Consciousness. Monitoring of verbal commands should be routine during moderate sedation, with the exception of young children and developmentally impaired, uncooperative patients, or when the response would be detrimental. During deep sedation the response to a more profound stimulus should be sought to ensure that the patient has not drifted into general anesthesia.

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  Physiologic Monitoring. All patients undergoing sedation/analgesia should be monitored by pulse oximetry with appropriate alarms. In addition, respiration should be continuously monitored by observation or auscultation. End-tidal carbon dioxide ( etco ₂ ) is encouraged for moderately sedated children and now required per AAP guideline for all patients receiving deep sedation and for those whose ventilation could not be directly observed during moderate sedation. It should be noted, however, that the ASA standards for basic monitoring were amended in 2012 to include etco ₂ monitoring of those sedated at moderate and deeper levels of sedation. In addition, the guidelines recommended that blood pressure should be determined before sedation/analgesia is initiated where possible and at regular intervals during the procedure, unless such monitoring interferes with the procedure (e.g., pediatric MRI, in which stimulation from the blood pressure cuff could arouse an appropriately sedated child). Electrocardiographic (ECG) monitoring should also be used in all children during deep sedation, and during moderate sedation, in those with significant cardiovascular disease, or those who are undergoing procedures in which dysrhythmias are anticipated.

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  Recording of Monitored Parameters. For both moderate and deep sedation, the child's level of consciousness, respiratory status, and hemodynamic variables should be assessed and recorded at a frequency commensurate with the type and amount of medication administered, the duration of the procedure, and the medical condition of the child. At a minimum, this should be (1) before the beginning of the procedure; (2) after administration of sedative/analgesic agents; (3) at regular intervals during the procedure; (4) during initial recovery; and (5) immediately before discharge. If recording is performed automatically, device alarms should be set to alert the care team to critical changes in patient status.

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  Availability of an Appropriately Trained and Skilled Individual Responsible for Patient Monitoring. A designated individual, other than the practitioner performing the procedure, should be present to monitor the child throughout procedures performed with sedation/analgesia. During deep sedation, this individual should have no other responsibilities. However, during moderate sedation, this individual may assist with minor, interruptible tasks once the patient's level of sedation/analgesia and vital signs have stabilized, provided that adequate monitoring for the child's level of sedation is maintained.

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  Training of Personnel. Individuals responsible for children who receive sedation/analgesia should understand the pharmacology of the medications that are administered, as well as the role of pharmacologic antagonists for opioids and benzodiazepines. Individuals who monitor children who receive sedation/analgesia should be able to recognize the associated complications. At least one individual capable of establishing a patent airway and positive-pressure ventilation, as well as a means for summoning additional assistance, should be present whenever sedation/analgesia is administered.

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  Availability of Emergency Equipment. Pharmacologic antagonists, as well as appropriately sized equipment for establishing a patent airway and providing positive-pressure ventilation with supplemental oxygen, should be present whenever sedation/analgesia is administered. Suction, advanced airway equipment, and resuscitation medications should be immediately available and in good working order. A functional defibrillator should be immediately available whenever deep sedation is administered and when moderate sedation is administered to those with mild or severe cardiovascular disease.

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  Use of Supplemental Oxygen. Equipment to administer supplemental oxygen should be present when sedation/analgesia is administered. Supplemental oxygen should be considered for moderate sedation and should be administered for deep sedation unless specifically contraindicated for a particular child or procedure. If hypoxemia is anticipated or develops during sedation/analgesia, supplemental oxygen should be administered.

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  Combinations of Sedative/Analgesic Agents. Combinations of sedative and analgesic agents may be administered as indicated for the procedure being performed and the condition of the child. Ideally, each component should be administered individually to achieve the desired effect (e.g., additional analgesic medication to relieve pain; additional sedative medication to decrease awareness or anxiety). The propensity for combinations of sedative and analgesic agents to cause respiratory depression and airway obstruction emphasizes the need to appropriately reduce the dose of each component, as well as the need to continually monitor respiratory function ( Fig. 48.4 ).

  

• ■

  Recovery Care. After sedation for diagnostic and therapeutic procedures, the children should be observed in an appropriately staffed and equipped area until they are near their baseline level of consciousness and are no longer at increased risk for cardiorespiratory depression. Oxygenation should be monitored periodically until they are no longer at risk for hypoxemia. Ventilation and circulation should be monitored at regular intervals until the children are suitable for discharge. Discharge criteria should be designed to minimize the risk of central nervous system (CNS) or cardiorespiratory depression after discharge from observation by trained personnel.

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  Consultation and Availability of an Anesthesiologist. Whenever possible, appropriate medical specialists should be consulted before sedating children with significant comorbidities. The choice of specialists depends on the nature of the underlying condition and the urgency of the situation. For severely compromised or medically unstable children (e.g., anticipated difficult airway, severe obstructive pulmonary disease, or congestive heart failure), practitioners who are not trained in the administration of general anesthesia should consult an anesthesiologist ( Table 48.6 ).

  TABLE 48.6

  Guidelines for the Consultation of an Anesthesiologist

  1. Medical Problems ASA physical status III or IV Pulmonary: airway obstruction (tonsils/adenoids)—loud snoring, obstructive sleep apnea. Poorly controlled asthma, congenital or acquired anomalies of the airway or face (Trisomy 21, Pierre Robin syndrome, Treacher Collins syndrome, Crouzon disease, tracheomalacia) Morbid obesity (≥2 times ideal body weight, BMI >30 kg/m 2 ) Cardiovascular: cyanosis, repaired or unrepaired congenital heart disease with significant symptoms of cyanosis or congestive heart failure Prematurity: less than 60 weeks postconception age at time of sedation Residual pulmonary, cardiovascular, gastrointestinal, neurologic problems Neurologic: developmental disabilities, poorly controlled seizures, central apnea Gastrointestinal: uncontrolled gastroesophageal reflux Severe liver or renal disease 2. Procedures requiring deep sedation in patients with a full stomach Emergency procedures 3. Management problems Severe developmental delay Patients who are difficult to control Severe attention-deficit disorder (paradoxically, the child may develop increased agitation during or after the procedure) 4. History of failed sedation Oversedation (loss of airway reflexes) Inability to adequately sedate Hyperactive (paradoxical) response to sedatives

  ASA , American Society of Anesthesiologists; BMI , body mass index.

The ASA also has numerous statements and guidelines for sedation by physicians other than anesthesiologists. The “Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists” was last updated in 2002 and, in many respects, is in concert with the AAP guidelines. The ASA currently has 10 different statements discussing sedation guidelines available through their website ( http://www.asahq.org ). Some statements specifically address questions related to the provision of moderate and deep sedation by nonanesthesiologists as well as the use of medications such as propofol by nonanesthesiologist sedationists. Most pertinent of these is the 2010 document “Statement on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners.” The guidelines include the following:

• 1.

  Formal training in administration of deep sedation during residency training (within 2 years) or an Accreditation Council for Graduate Medical Education accredited training program

• 2.

  Experience and competency in managing sedated patients

• 3.

  Clinical experience with more than 35 patients

• 4.

  Knowledge of ASA guidelines

• 5.

  Advanced cardiac life support training

• 6.

  Quality assurance tracking

Separate privileging is required for the care of children. The exact nature of these requirements are not specified, but pediatric sedation training over and above baseline competencies is advised.

Other organizations, notably the American College of Emergency Physicians (ACEP), have published their own sedation guidelines and clinical practice advisories for sedation. These guidelines are distinguishable from the AAP and ASA guidelines in several respects, including the definition of the continuum of sedation. The ACEP guideline prefers the term “procedural sedation.” It is defined “as a technique of administering sedatives, analgesics, dissociative agents, alone or in combination to induce a state that allows the child to tolerate unpleasant procedures while maintaining cardiopulmonary function.” It is intended to result in a depressed level of consciousness but one that allows the child to “independently and continuously” control his or her own airway. This guideline was updated in 2014 to address several issues with the following recommendations :

• 1.

  Do not delay procedural sedation in adults or children in the emergency department based on fasting time. Preprocedural fasting for any duration has not reduced the risk of emesis or aspiration when administering procedural sedation and analgesia.

• 2.

  Capnography may be used as an adjunct to pulse oximetry and as a clinical tool to detect hypoventilation and apnea earlier than pulse oximetry and/or clinical assessment alone in children undergoing procedural sedation and analgesia in the ED.

• 3.

  During procedural sedation and analgesia, a nurse or other qualified individual should be present to continually observe and monitor the patient, in addition to the provider performing the procedure. Physicians who are working or consulting in the emergency department should coordinate procedures requiring procedural sedation and analgesia with the emergency department staff.

• 4.

  Ketamine and etomidate can be safely administered individually to children and propofol can be administered to both children and adults for procedural sedation and analgesia in the emergency department. A combination of propofol and ketamine can be safely administered to children and adults for procedural sedation and analgesia.

The ACEP suggests a very different clinical practice advisory for the fasting interval before sedation based on analysis of reports from the sedation literature and expert consensus. The suggested time frames for fasting start with a 3-hour baseline and vary based on the urgency of the procedure and the planned depth of sedation. In addition, the practitioner can be directing the sedation and performing the procedure, and there is vague language regarding the nurse observer. The result is a strategy that differs significantly from the standard recommendations from the AAP and ASA.

It is mandatory that sedation policies used in hospitals conform to JCAHO standards that have been derived from the Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS). These requirements are consistent with the AAP/ASA guidelines but are more explicit in terms of the oversight of sedation services. The standards require documentation (e.g., medical history, physical status, and record-keeping during the procedure and the recovery from the procedure), a fasting protocol, and informed consent procedures that are mandatory for all those undergoing sedation, regardless of the nature, duration, patient's history, and location of the procedure. Similarly, the sedation personnel, monitoring equipment, and recovery facilities must meet uniform standards within an institution. Hospitals risk losing federal funding if they fail to comply. In the most recent CMS regulations published in 2011, the leadership and responsibilities for the delivery of deep sedation are assigned to a “qualified doctor of medicine or osteopathy who leads the department of anesthesia services.” This would logically fall under the purview of the Chair of the Department of Anesthesiology in most cases; however, there are many small or unique hospitals where such a position does not exist. In such cases, the hospital administration must designate a physician who will fill this role and meet these qualifications ( Fig. 48.5 ).

Under the CMS directives, deep sedation is placed under anesthesia services and subject to the anesthesia administration requirements at 42 CFR 482.52(a): whereas minimal and moderate sedation are placed under analgesia/sedation and therefore not subject to anesthesia administrative requirements. To ensure continuity and equanimity of sedation care, CMS states that there should be one anesthesia service that has responsibility for oversight of all anesthesia services. Anesthesia must be administered by a (1) qualified anesthesiologist; (2) certified registered nurse anesthetist (CRNA) or anesthesiologist assistant (AA) with appropriate supervision; (3) doctor of medicine or osteopathy (other than an anesthesiologist); and (4) dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state regulations. Credentialing and privileging must be done per hospital policy and is the responsibility of the hospital's director of anesthesia services. The appropriateness and quality of anesthesia, including sedation, must be reviewed and approved by the director of anesthesia services. The standards for sedation require that each hospital develop specific appropriate protocols for patients receiving sedation, but these guidelines offer little detail on the exact content of the protocols (those are left to the individual organizations). These protocols must include delineation of the following:

• 1.

  Qualified individuals in sufficient numbers to perform and monitor patients during and after the procedure. A registered nurse must supervise perioperative nursing care.

• 2.

  Competency-based education, training, and experience in evaluating patients. These must include the following:

  • a.

    Evaluating patients before the sedation.

  • b.

    Performing moderate and deep sedation, including rescuing patients who slip into a deeper than desired level of sedation. These include the following:

    • i.

      Moderate sedation—personnel are qualified to rescue patients from deep sedation and are competent to manage a compromised airway and to provide adequate oxygenation and ventilation.

    • ii.

      Deep sedation—personnel are qualified to rescue patients from general anesthesia and are competent to manage an unstable cardiovascular system, as well as a compromised airway and inadequate oxygenation and ventilation.

• 3.

  Appropriate equipment for care and resuscitation.

• 4.

  The following must occur before moderate or deep sedation:

  • a.

    Appropriate needs of the patient are assessed.

  • b.

    Preprocedural education is provided to the patient according to a plan of care.

  • c.

    A time-out is conducted immediately before starting, as described in universal protocol.

  • d.

    A licensed independent practitioner plans or concurs with the planned procedure.

• 5.

  Appropriate monitoring of vital signs during and after the procedure, including, but not limited to, heart rate and oxygenation using pulse oximetry, respiratory frequency and adequacy of pulmonary ventilation, monitoring of blood pressure at regular levels, and cardiac monitoring (by ECG or use of a continuous cardiac monitoring device) in patients with significant cardiovascular disease or when dysrhythmias are anticipated or detected.

• 6.

  Documentation of care before, during, and after the procedure.

• 7.

  Monitoring of outcomes. In particular, analysis of data is performed on adverse events or patterns of adverse events during moderate or deep sedation.

The guidelines for sedation are actually quite similar among the various organizations and government entities that are responsible for these standards. It is critical that anesthesiologists who oversee and coordinate this care be familiar with the various guidelines and help their colleagues meet or exceed them.