Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures: An Update ...
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CLINICAL REPORT
Guidelines for Monitoring and Guidance for the Clinician in Rendering
Pediatric Care
Management of Pediatric Patients
During and After Sedation for
Diagnostic and Therapeutic
Procedures: An Update
AMERICAN ACADEMY OF PEDIATRICS
AMERICAN ACADEMY OF PEDIATRIC DENTISTRY
Charles J. Coté, MD, Stephen Wilson, DMD, MA, PhD, the Work Group on Sedation
ABSTRACT
The safe sedation of children for procedures requires a systematic approach that
includes the following: no administration of sedating medication without the
safety net of medical supervision; careful presedation evaluation for underlying
medical or surgical conditions that would place the child at increased risk from
sedating medications; appropriate fasting for elective procedures and a balance
between depth of sedation and risk for those who are unable to fast because of the
urgent nature of the procedure; a focused airway examination for large tonsils or
anatomic airway abnormalities that might increase the potential for airway ob- www.pediatrics.org/cgi/doi/10.1542/
struction; a clear understanding of the pharmacokinetic and pharmacodynamic peds.2006-2780
effects of the medications used for sedation, as well as an appreciation for drug doi:10.1542/peds.2006-2780
interactions; appropriate training and skills in airway management to allow rescue All clinical reports from the American
Academy of Pediatrics automatically
of the patient; age- and size-appropriate equipment for airway management and expire 5 years after publication unless
venous access; appropriate medications and reversal agents; sufficient numbers of reaffirmed, revised, or retired at or
people to carry out the procedure and monitor the patient; appropriate physiologic before that time.
monitoring during and after the procedure; a properly equipped and staffed The guidance in this report does not
indicate an exclusive course of treatment
recovery area; recovery to presedation level of consciousness before discharge or serve as a standard of medical care.
from medical supervision; and appropriate discharge instructions. This report was Variations, taking into account individual
developed through a collaborative effort of the American Academy of Pediatrics circumstances, may be appropriate.
and the American Academy of Pediatric Dentistry to offer pediatric providers Key Words
sedation, guidelines, procedures, adverse
updated information and guidance in delivering safe sedation to children. events, outcomes, accidents, prevention,
monitoring, drug interactions, pediatric,
children
Abbreviations
INTRODUCTION AAP—American Academy of Pediatrics
AAPD—American Academy of Pediatric
Invasive diagnostic and minor surgical procedures on pediatric patients outside the Dentistry
traditional operating room setting have increased in the last decade. As a conse- ASA—American Society of
quence of this change and the increased awareness of the importance of providing Anesthesiologists
EMS— emergency medical services
analgesia and anxiolysis, the need for sedation for procedures in physician offices, ECG— electrocardiography
dental offices, subspecialty procedure suites, imaging facilities, emergency depart- LMA—laryngeal mask airway
ments, and ambulatory surgery centers has also markedly increased.1–37 In recog- PEDIATRICS (ISSN Numbers: Print, 0031-4005;
Online, 1098-4275). Copyright © 2006 by the
nition of this need for both elective and emergency use of sedation in nontradi- American Academy of Pediatrics and the
tional settings, the American Academy of Pediatrics (AAP) and American Academy American Academy of Pediatric Dentistry
PEDIATRICS Volume 118, Number 6, December 2006 2587
Downloaded from www.aappublications.org/news by guest on February 22, 2020of Pediatric Dentistry (AAPD) have published a series of their behavior.57 Therefore, the need for deep sedation
guidelines for the monitoring and management of pedi- should be anticipated. Children in this age group are
atric patients during and after sedation for a proce- particularly vulnerable to the sedating medication’s ef-
dure.38–42 The purpose of this updated statement is to fects on respiratory drive, patency of the airway, and
unify the guidelines for sedation used by medical and protective reflexes.46 Studies have shown that it is com-
dental practitioners, add clarifications regarding moni- mon for children to pass from the intended level of
toring modalities, provide new information from medi- sedation to a deeper, unintended level of sedation.56,59,70
cal and dental literature, and suggest methods for further For older and cooperative children, other modalities,
improvement in safety and outcomes. With the revision such as parental presence, hypnosis, distraction, topical
of this document, the Joint Commission on Accredita- local anesthetics, and guided imagery, may reduce the
tion of Healthcare Organizations, the American Society need for or the needed depth of pharmacologic seda-
of Anesthesiologists (ASA), the AAP, and the AAPD will tion.31,71–81
use similar language to define sedation categories and The concept of rescue is essential to safe sedation.
the expected physiologic responses.41–44 Practitioners of sedation must have the skills to rescue
This revised statement reflects the current under- the patient from a deeper level than that intended for
standing of appropriate monitoring needs both during the procedure. For example, if the intended level of
and after sedation for a procedure.4,5,12,19,21,22,26,45–53 The sedation is “minimal,” practitioners must be able to res-
monitoring and care outlined in these guidelines may be cue the patient from “moderate sedation”; if the in-
exceeded at any time on the basis of the judgment of the tended level of sedation is “moderate,” practitioners
responsible practitioner. Although intended to encour- must have the skills to rescue the patient from “deep
age high-quality patient care, adherence to these guide- sedation”; and if the intended level of sedation is “deep,”
lines cannot guarantee a specific patient outcome. How- practitioners must have the skills to rescue the patient
ever, structured sedation protocols designed to from a state of “general anesthesia.” The ability to res-
incorporate the principles in this document have been cue means that practitioners must be able to recognize
widely implemented and shown to reduce morbidi- the various levels of sedation and have the skills neces-
ty.29,32–34,37,54,55 These guidelines are proffered with the sary to provide appropriate cardiopulmonary support
awareness that, regardless of the intended level of seda- if needed. Sedation and anesthesia in a nonhospital en-
tion or route of administration, the sedation of a pedi- vironment (private physician or dental office or free-
atric patient represents a continuum and may result in standing imaging facility) may be associated with an
respiratory depression and loss of the patient’s protective increased incidence of “failure to rescue” the patient
reflexes.43,56–59 should an adverse event occur, because the only backup
Sedation of pediatric patients has serious associ- in this venue may be to activate emergency medical
ated risks, such as hypoventilation, apnea, airway ob- services (EMS).46,82 Rescue therapies require specific
struction, laryngospasm, and cardiopulmonary impair- training and skills.46,54,83,84 Maintenance of the skills
ment.2,6,22,45,46,54,60–69 These adverse responses during and needed to perform successful bag-valve-mask ventila-
after sedation for a diagnostic or therapeutic procedure tion is essential to successfully rescue a child who has
may be minimized, but not completely eliminated, by a become apneic or developed airway obstruction. Famil-
careful preprocedure review of the patient’s underlying iarity with emergency airway management procedure
medical conditions and consideration of how the seda- algorithms is essential.83–87 Practitioners should have an
tion process might affect or be affected by these condi- in-depth knowledge of the agents they intend to use and
tions.54 Appropriate drug selection for the intended pro- their potential complications. A number of reviews and
cedure as well as the presence of an individual with the handbooks for sedating pediatric patients are avail-
skills needed to rescue a patient from an adverse re- able.32,48,55,88–93 These guidelines are intended for all ven-
sponse are essential. Appropriate physiologic monitoring ues in which sedation for a procedure might be per-
and continuous observation by personnel not directly formed (hospital, surgical center, freestanding imaging
involved with the procedure allow for accurate and rapid facility, dental facility, or private office).
diagnosis of complications and initiation of appropriate There are other guidelines for specific situations and
rescue interventions.46,51,54 personnel that are beyond the scope of this document.
The sedation of children is different from the sedation Specifically, guidelines for the delivery of general anes-
of adults. Sedation in children is often administered to thesia and monitored anesthesia care (sedation or anal-
control behavior to allow the safe completion of a pro- gesia), outside or within the operating room by anesthe-
cedure. A child’s ability to control his or her own behav- siologists or other practitioners functioning within a
ior to cooperate for a procedure depends both on his or department of anesthesiology, are addressed by policies
her chronologic and developmental age. Often, children developed by the ASA and by individual departments of
younger than 6 years and those with developmental anesthesiology.94 Also, guidelines for the sedation of pa-
delay require deep levels of sedation to gain control of tients undergoing mechanical ventilation in a critical
2588 AMERICAN ACADEMY OF PEDIATRICS
Downloaded from www.aappublications.org/news by guest on February 22, 2020care environment or for providing analgesia for patients ● Deep sedation (deep sedation/analgesia): a drug-in-
postoperatively, patients with chronic painful condi- duced depression of consciousness during which pa-
tions, and hospice care are also beyond the scope of this tients cannot be easily aroused but respond purpose-
document. fully (see discussion of reflex withdrawal above) after
repeated verbal or painful stimulation (eg, purpose-
DEFINITION OF TERMS USED IN THIS REPORT fully pushing away the noxious stimuli). The ability to
● Pediatric patients: all patients through 21 years of age, independently maintain ventilatory function may be
as defined by the AAP. impaired. Patients may require assistance in maintain-
ing a patent airway, and spontaneous ventilation may
● Must/shall: an imperative need or duty that is essen- be inadequate. Cardiovascular function is usually
tial, indispensable, or mandatory. maintained. A state of deep sedation may be accom-
● Should: the recommended need and/or duty. panied by partial or complete loss of protective airway
● May/could: freedom or liberty to follow a suggested or reflexes.
reasonable alternative. ● General anesthesia: a drug-induced loss of conscious-
● Medical supervision/medical personnel: a currently li- ness during which patients are not arousable, even by
censed practitioner of medicine, surgery, or dentistry painful stimulation. The ability to independently
trained in the administration of medications used for maintain ventilatory function is often impaired. Pa-
procedural sedation and the management of compli- tients often require assistance in maintaining a patent
cations associated with these medications. airway, and positive-pressure ventilation may be re-
quired because of depressed spontaneous ventilation
● Encouraged: a suggested or reasonable action to be or drug-induced depression of neuromuscular func-
taken. tion. Cardiovascular function may be impaired.
● ASA physical status classification: guidelines for clas-
sifying the baseline health status according to the ASA
(see Appendix 1). GOALS OF SEDATION
The goals of sedation in the pediatric patient for diag-
● Minimal sedation (formerly anxiolysis): a drug-in- nostic and therapeutic procedures are to (1) guard the
duced state during which patients respond normally to patient’s safety and welfare; (2) minimize physical dis-
verbal commands; although cognitive function and comfort and pain; (3) control anxiety, minimize psycho-
coordination may be impaired, ventilatory and cardio- logical trauma, and maximize the potential for amnesia;
vascular functions are unaffected. (4) control behavior and/or movement to allow the safe
● Moderate sedation (formerly conscious sedation or completion of the procedure; and (5) return the patient
sedation/analgesia): a drug-induced depression of to a state in which safe discharge from medical supervi-
consciousness during which patients respond pur- sion, as determined by recognized criteria, is possible
posefully to verbal commands (eg, “open your eyes,” (Appendix 2).
either alone or accompanied by light tactile stimula- These goals can best be achieved by selecting the lowest
tion, such as a light tap on the shoulder or face, not a dose of drug with the highest therapeutic index for the
sternal rub). For older patients, this level of sedation procedure. It is beyond the scope of this document to
implies an interactive state; for younger patients, age- specify which drugs are appropriate for which procedures;
appropriate behaviors (eg, crying) occur and are ex- however, the selection of the fewest number of drugs and
pected. Reflex withdrawal, although a normal re- matching drug selection to the type and goal of the proce-
sponse to a painful stimulus, is not considered as the dure are essential for safe practice.53,88,91–93,95–97 For example,
only age-appropriate purposeful response (ie, it must analgesic medications such as opioids are indicated for
be accompanied by another response, such as pushing painful procedures. For nonpainful procedures, such as
away the painful stimulus, to confirm a higher cogni- computed tomography or MRI, sedatives/hypnotics are
tive function). With moderate sedation, no interven- preferred. When both sedation and analgesia are desirable
tion is required to maintain a patent airway, and spon- (eg, fracture reduction), either single agents with analgesic/
taneous ventilation is adequate. Cardiovascular sedative properties or combination regimens are com-
function is usually maintained. However, in the case monly used. Anxiolysis and amnesia are additional goals
of procedures that may themselves cause airway ob- that should be considered in selection of agents for partic-
struction (eg, dental or endoscopic), the practitioner ular patients. However, the potential for an adverse out-
must recognize an obstruction and assist the patient in come may be increased when 3 or more sedating medica-
opening the airway. If the patient is not making spon- tions are administered.45,98 Knowledge of each drug’s time
taneous efforts to open their airway to relieve the of onset, peak response, and duration of action is essential.
obstruction, then the patient should be considered to Although the concept of titration of drug to effect is critical,
be deeply sedated. one must know whether the previous dose has taken full
PEDIATRICS Volume 118, Number 6, December 2006 2589
Downloaded from www.aappublications.org/news by guest on February 22, 2020effect before administering additional drug. Such manage- should be understood that the availability of EMS ser-
ment will improve safety and outcomes. Drugs with long vices does not replace the practitioner’s responsibility to
durations of action (eg, chloral hydrate, intramuscular pen- provide initial rescue in managing life-threatening com-
tobarbital, phenothiazines) will require longer periods of plications.
observation even after the child achieves currently used
recovery and discharge criteria.45,99,100 This concept is par- On-Site Monitoring and Rescue Equipment
ticularly important for infants and toddlers transported in An emergency cart or kit must be immediately accessi-
car safety seats who are at risk of resedation after discharge ble. This cart or kit must contain equipment to provide
because of residual prolonged drug effects with the poten- the necessary age- and size-appropriate drugs and equip-
tial for airway obstruction.45,46 ment to resuscitate a nonbreathing and unconscious
child. The contents of the kit must allow for the provi-
GENERAL GUIDELINES sion of continuous life support while the patient is being
transported to a medical facility or to another area
Candidates
within a medical facility. All equipment and drugs must
Patients who are in ASA classes I and II (Appendix 1) are
be checked and maintained on a scheduled basis (see
frequently considered appropriate candidates for mini-
Appendices 3 and 4 for suggested drugs and emergency
mal, moderate, or deep sedation. Children in ASA classes
life support equipment to consider before the need for
III and IV, children with special needs, and those with
rescue occurs). Monitoring devices, such as electrocar-
anatomic airway abnormalities or extreme tonsillar hy-
diography (ECG) machines, pulse oximeters (with size-
pertrophy present issues that require additional and in-
appropriate oximeter probes), end-tidal carbon dioxide
dividual consideration, particularly for moderate and
monitors, and defibrillators (with size-appropriate defi-
deep sedation.51 Practitioners are encouraged to consult
brillator paddles), must have a safety and function check
with appropriate subspecialists and/or an anesthesiolo-
on a regular basis as required by local or state regulation.
gist for patients at increased risk of experiencing adverse
sedation events because of their underlying medical/
Documentation
surgical conditions.
Documentation before sedation shall include, but not be
limited to, the guidelines that follow.
Responsible Person
The pediatric patient shall be accompanied to and from 1. Informed consent: the patient record shall document
the treatment facility by a parent, legal guardian, or that appropriate informed consent was obtained ac-
other responsible person. It is preferable to have 2 or cording to local, state, and institutional require-
more adults accompany children who are still in car ments.102
safety seats if transportation to and from a treatment 2. Instructions and information provided to the respon-
facility is provided by one of the adults.101 sible person: the practitioner shall provide verbal
and/or written instructions to the responsible person.
Facilities Information shall include objectives of the sedation
The practitioner who uses sedation must have immedi- and anticipated changes in behavior during and after
ately available facilities, personnel, and equipment to sedation. Special instructions shall be given to the
manage emergency and rescue situations. The most responsible adult for infants and toddlers who will be
common serious complications of sedation involve com- transported home in a car safety seat regarding the
promise of the airway or depressed respirations resulting need to carefully observe the child’s head position to
in airway obstruction, hypoventilation, hypoxemia, and avoid airway obstruction. Transportation in a car
apnea. Hypotension and cardiopulmonary arrest may safety seat poses a particular risk for infants who have
occur, usually from inadequate recognition and treat- received medications known to have a long half-life,
ment of respiratory compromise. Other rare complica- such as chloral hydrate, intramuscular pentobarbital,
tions may also include seizures and allergic reactions. or phenothiazine.45,46,100,103 Consideration for a longer
Facilities that provide pediatric sedation should monitor period of observation shall be given if the responsible
for, and be prepared to treat, such complications. person’s ability to observe the child is limited (eg,
only 1 adult who also has to drive). Another indica-
Back-up Emergency Services tion for prolonged observation would be a child with
A protocol for access to back-up emergency services shall an anatomic airway problem or a severe underlying
be clearly identified with an outline of the procedures medical condition. A 24-hour telephone number for
necessary for immediate use. For nonhospital facilities, a the practitioner or his or her associates shall be pro-
protocol for ready access to ambulance service and im- vided to all patients and their families. Instructions
mediate activation of the EMS system for life-threaten- shall include limitations of activities and appropriate
ing complications must be established and maintained. It dietary precautions.
2590 AMERICAN ACADEMY OF PEDIATRICS
Downloaded from www.aappublications.org/news by guest on February 22, 2020Dietary Precautions stance, the use of sedation must be preceded by an
Agents used for sedation have the potential to impair evaluation of food and fluid intake. There are few pub-
protective airway reflexes, particularly during deep se- lished studies with adequate statistical power to provide
dation. Although a rare occurrence, pulmonary aspira- guidance to the practitioner regarding safety or risk of
tion may occur if the child regurgitates and cannot pro- pulmonary aspiration of gastric contents during proce-
tect his or her airway. Therefore, it is prudent that, dural sedation.104–109 When protective airway reflexes are
before sedation, the practitioner evaluate preceding food lost, gastric contents may be regurgitated into the air-
and fluid intake. It is likely that the risk of aspiration way. Therefore, patients with a history of recent oral
during procedural sedation differs from that during gen- intake or with other known risk factors, such as trauma,
eral anesthesia involving tracheal intubation or other decreased level of consciousness, extreme obesity, preg-
airway manipulation.104,105 However, because the abso- nancy, or bowel motility dysfunction, require careful
lute risk of aspiration during procedural sedation is not evaluation before administration of sedatives. When
yet known, guidelines for fasting periods before elective proper fasting has not been ensured, the increased risks
sedation should generally follow those used for elective of sedation must be carefully weighed against its bene-
general anesthesia. For emergency procedures in chil- fits, and the lightest effective sedation should be used.
dren who have not fasted, the risks of sedation and the The use of agents with less risk of depressing protective
possibility of aspiration must be balanced against the airway reflexes may be preferred.110 Some emergency
benefits of performing the procedure promptly (see be- patients requiring deep sedation may require protection
low). Additional research is needed to better elucidate of the airway before sedation.
the relationships between various fasting intervals and
sedation complications. Use of Immobilization Devices
Immobilization devices such as papoose boards must be
Before Elective Sedation applied in such a way as to avoid airway obstruction or
Children receiving sedation for elective procedures chest restriction. The child’s head position and respira-
should generally follow the same fasting guidelines as tory excursions should be checked frequently to ensure
those for general anesthesia (Table 1). It is permissible airway patency. If an immobilization device is used, a
for routine necessary medications to be taken with a sip hand or foot should be kept exposed, and the child
of water on the day of the procedure. should never be left unattended. If sedating medications
are administered in conjunction with an immobilization
Before Emergency Sedation device, monitoring must be used at a level consistent
The practitioner must always balance the possible risks with the level of sedation achieved.
of sedating nonfasted patients with the benefits and
necessity for completing the procedure. In this circum- Documentation at the Time of Sedation
1. Health evaluation: before sedation, a health evalua-
TABLE 1 Appropriate Intake of Food and Liquids Before Elective
tion shall be performed by an appropriately licensed
Sedation
practitioner and reviewed by the sedation team at the
Ingested Material Minimum Fasting
Period, h time of treatment for possible interval changes. The
purpose of this evaluation is to not only document
Clear liquids: water, fruit juices without 2
pulp, carbonated beverages, clear tea, baseline status but also determine if patients present
black coffee specific risk factors that may warrant additional con-
Breast milk 4 sultation before sedation. This evaluation will also
Infant formula 6 screen out patients whose sedation will require more
Nonhuman milk: because nonhuman milk 6
advanced airway or cardiovascular management
is similar to solids in gastric emptying
time, the amount ingested must be skills or alterations in the doses or types of medica-
considered when determining an tions used for procedural sedation.
appropriate fasting period A new concern for the practitioner is the wide-
Light meal: a light meal typically consists 6 spread use of medications that may interfere with
of toast and clear liquids. Meals that
drug absorption or metabolism and, therefore, en-
include fried or fatty foods or meat may
prolong gastric emptying time; both hance or shorten the effect time of sedating medica-
the amount and type of foods ingested tions. Herbal medicines (eg, St John’s wort or echi-
must be considered when determining nacea), may alter drug pharmacokinetics through
an appropriate fasting period inhibition of the cytochrome P450 system, resulting
Source: American Society of Anesthesiologists. Practice guidelines for preoperative fasting and in prolonged drug effect and altered (increased or
the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to
healthy patients undergoing elective procedures—a report of the American Society of Anes- decreased) blood drug concentrations.111–116 Kava may
thesiologists. Available at: www.asahq.org/publicationsAndServices/NPO.pdf. increase the effects of sedatives by potentiating
PEDIATRICS Volume 118, Number 6, December 2006 2591
Downloaded from www.aappublications.org/news by guest on February 22, 2020␥-aminobutyric acid inhibitory neurotransmission, presedation health; however, a brief note shall be
and valerian may itself produce sedation that appar- written documenting that the chart was reviewed,
ently is mediated through modulation of ␥-aminobu- positive findings were noted, and a management plan
tyric acid neurotransmission and receptor func- was formulated. If the clinical or emergency condi-
tion.117,118 Drugs such as erythromycin, cimetidine, tion of the patient precludes acquiring complete in-
and others may also inhibit the cytochrome P450 formation before sedation, this health evaluation
system, resulting in prolonged sedation with midazo- should be obtained as soon as is feasible.
lam as well as other medications competing for the 2. Prescriptions: when prescriptions are used for seda-
same enzyme systems.119–122 Medications used to treat tion, a copy of the prescription or a note describing
HIV infection, some anticonvulsants, and some psych- the content of the prescription should be in the pa-
otropic medications may also produce clinically impor- tient’s chart along with a description of the instruc-
tant drug-drug interactions.123–125 Therefore, carefully tions that were given to the responsible person. Pre-
obtaining a drug history is a vital part of the safe seda- scription medications intended to accomplish procedural
tion of children. The clinician should consult various sedation must not be administered without the benefit of
sources (a pharmacist, textbooks, online services, or direct supervision by trained medical personnel. Adminis-
handheld databases) for specific information on drug tration of sedating medications at home poses an
interactions.126 unacceptable risk, particularly for infants and pre-
The health evaluation should include: school-aged children traveling in car safety seats.46
● obtaining age and weight
● obtaining a health history, including (1) allergies Documentation During Treatment
and previous allergic or adverse drug reactions; (2) The patient’s chart shall contain a time-based record that
medication/drug history, including dosage, time, includes the name, route, site, time, dosage, and patient
route, and site of administration for prescription, effect of administered drugs. Before sedation, a “time
over-the-counter, herbal, or illicit drugs; (3) rele- out” should be performed to confirm the patient’s name,
vant diseases, physical abnormalities, and neuro- procedure to be performed, and site of the procedure.43
logic impairment that might increase the potential During administration, the inspired concentrations of
for airway obstruction, such as a history of snoring oxygen and inhalation sedation agents and the duration
or obstructive sleep apnea127,128; (4) pregnancy sta- of their administration shall be documented. Before drug
tus; (5) a summary of previous relevant hospital- administrations, special attention must be paid to calcu-
izations; (6) history of sedation or general anesthe- lation of dosage (ie, mg/kg). The patient’s chart shall
sia and any complications or unexpected responses; contain documentation at the time of treatment that the
and (7) relevant family history, particularly that patient’s level of consciousness and responsiveness,
related to anesthesia heart rate, blood pressure, respiratory rate, and oxygen
saturation were monitored until the patient attained
● a review of systems with a special focus on abnor-
predetermined discharge criteria (see Appendix 2). A
malities of cardiac, pulmonary, renal, or hepatic
variety of sedation-scoring systems are available and
function that might alter the child’s expected re-
may aid this process.70,100 Adverse events and their treat-
sponses to sedating/analgesic medications
ment shall be documented.
● determination of vital signs, including heart rate,
blood pressure, respiratory rate, and temperature
Documentation After Treatment
(for some children who are very upset or nonco-
The time and condition of the child at discharge from the
operative, this may not be possible, and a note
treatment area or facility shall be documented; this
should be written to document this occurrence)
should include documentation that the child’s level of
● a physical examination, including a focused evalu- consciousness and oxygen saturation in room air have
ation of the airway (tonsillar hypertrophy, abnor- returned to a state that is safe for discharge by recog-
mal anatomy [eg, mandibular hypoplasia]) to de- nized criteria (see Appendix 2). Patients receiving sup-
termine if there is an increased risk of airway plemental oxygen before the procedure should have a
obstruction54,129,130 similar oxygen need after the procedure. Because some
● a physical status evaluation (ASA classification [see sedation medications are known to have a long half-life
Appendix 1]) and may delay a patient’s complete return to baseline or
pose the risk of resedation,45,103,131,132 some patients might
● obtaining name, address, and telephone number of benefit from a longer period of less-intense observation
the child’s medical home (eg, a step-down observation area) before discharge
For hospitalized patients, the current hospital from medical supervision.133 Several scales to evaluate
record may suffice for adequate documentation of recovery have been devised and validated.70,134,135 A re-
2592 AMERICAN ACADEMY OF PEDIATRICS
Downloaded from www.aappublications.org/news by guest on February 22, 2020cently described and simple evaluation tool may be the Moderate Sedation
ability of the infant or child to remain awake for at least Moderate sedation (formerly conscious sedation or se-
20 minutes when placed in a quiet environment.100 dation/analgesia) is a drug-induced depression of con-
sciousness during which patients respond purposefully
CONTINUOUS QUALITY IMPROVEMENT to verbal commands or light tactile stimulation (see
The essence of medical error reduction is a careful ex- “Definition of Terms Used in This Report”). No interven-
amination of index events and root-cause analysis of tions are required to maintain a patent airway, and
how the event could be avoided in the future.136–140 spontaneous ventilation is adequate. Cardiovascular
Therefore, each facility should maintain records that function is usually maintained. The caveat that loss of
track adverse events such as desaturation, apnea, laryn- consciousness should be unlikely is a particularly impor-
gospasm, the need for airway interventions including tant aspect of the definition of moderate sedation. The
jaw thrust or positive pressure ventilation, prolonged drugs and techniques used should carry a margin of
sedation, unanticipated use of reversal agents, unin- safety wide enough to render unintended loss of con-
tended or prolonged hospital admission, and unsatisfac- sciousness highly unlikely. Because the patient who re-
tory sedation/analgesia/anxiolysis. Such events can then ceives moderate sedation may progress into a state of
be examined for assessment of risk reduction and im- deep sedation and obtundation, the practitioner should
provement in patient satisfaction. be prepared to increase the level of vigilance correspond-
ing to what is necessary for deep sedation.56
PREPARATION AND SETUP FOR SEDATION PROCEDURES
Part of the safety net of sedation is to use a systematic Personnel
approach so as to not overlook having an important
The Practitioner
drug, piece of equipment, or monitor immediately avail-
The practitioner responsible for the treatment of the
able at the time of a developing emergency. To avoid this
patient and/or the administration of drugs for sedation
problem, it is helpful to use an acronym that allows the must be competent to use such techniques, provide the
same setup and checklist for every procedure. A com- level of monitoring provided in these guidelines, and
monly used acronym that is useful in planning and manage complications of these techniques (ie, to be able
preparation for a procedure is SOAPME: to rescue the patient). Because the level of intended
S (suction)—size-appropriate suction catheters and a func- sedation may be exceeded, the practitioner must be suf-
tioning suction apparatus (eg, Yankauer-type suction) ficiently skilled to provide rescue should the child
O (oxygen)—adequate oxygen supply and functioning progress to a level of deep sedation. The practitioner
flow meters/other devices to allow its delivery must be trained in, and capable of providing, at the
A (airway)—size-appropriate airway equipment (naso- minimum, bag-valve-mask ventilation to be able to
pharyngeal and oropharyngeal airways, laryngoscope oxygenate a child who develops airway obstruction or
blades [checked and functioning], endotracheal tubes,
apnea. Training in, and maintenance of, advanced pedi-
stylets, face mask, bag-valve-mask or equivalent device
atric airway skills is required; regular skills reinforce-
[functioning])
P (pharmacy)—all the basic drugs needed to support life ment is strongly encouraged.
during an emergency, including antagonists as indicated Support Personnel
M (monitors)—functioning pulse oximeter with size- The use of moderate sedation shall include provision
appropriate oximeter probes141,142 and other monitors as of a person, in addition to the practitioner, whose re-
appropriate for the procedure (eg, noninvasive blood pres- sponsibility is to monitor appropriate physiologic param-
sure, end-tidal carbon dioxide, ECG, stethoscope) eters and to assist in any supportive or resuscitation
E (equipment)—special equipment or drugs for a partic-
measures if required. This individual may also be re-
ular case (eg, defibrillator)
sponsible for assisting with interruptible patient-related
SPECIFIC GUIDELINES FOR INTENDED LEVEL OF SEDATION tasks of short duration.44 This individual must be trained
in and capable of providing pediatric basic life support.
Minimal Sedation The support person shall have specific assignments in
Minimal sedation (formerly anxiolysis) is a drug-in- the event of an emergency and current knowledge of the
duced state during which patients respond normally to emergency cart inventory. The practitioner and all an-
verbal commands. Although cognitive function and co- cillary personnel should participate in periodic reviews
ordination may be impaired, ventilatory and cardiovas- and practice drills of the facility’s emergency protocol to
cular functions are unaffected. Children who have re- ensure proper function of the equipment and coordina-
ceived minimal sedation generally will not require more tion of staff roles in such emergencies.
than observation and intermittent assessment of their
level of sedation. Some children will become moderately Monitoring and Documentation
sedated despite the intended level of minimal sedation; Baseline
should this occur, the guidelines for moderate sedation Before administration of sedative medications, a base-
will apply.56 line determination of vital signs shall be documented.
PEDIATRICS Volume 118, Number 6, December 2006 2593
Downloaded from www.aappublications.org/news by guest on February 22, 2020For some children who are very upset or noncoopera- least 1 individual must be present who is trained in, and
tive, this may not be possible, and a note should be capable of, providing advanced pediatric life support and
written to document this happenstance. who is skilled in airway management and cardiopulmo-
nary resuscitation; training in pediatric advanced life
During the Procedure
support is required.
The practitioner shall document the name, route, site,
time of administration, and dosage of all drugs adminis-
tered. There shall be continuous monitoring of oxygen Equipment
saturation and heart rate and intermittent recording of In addition to the equipment previously cited for mod-
respiratory rate and blood pressure; these should be erate sedation, an ECG monitor and a defibrillator for
recorded in a time-based record. Restraining devices use in pediatric patients should be readily available.
should be checked to prevent airway obstruction or
chest restriction. If a restraint device is used, a hand or Vascular Access
foot should be kept exposed. The child’s head position Patients receiving deep sedation should have an intra-
should be checked frequently to ensure airway patency. venous line placed at the start of the procedure or have
A functioning suction apparatus must be present. a person skilled in establishing vascular access in pedi-
atric patients immediately available.
After the Procedure
The child who has received moderate sedation must
be observed in a suitably equipped recovery facility (ie, Monitoring
the facility must have functioning suction apparatus as A competent individual shall observe the patient contin-
well as the capacity to deliver more than 90% oxygen uously. The monitoring shall include all parameters de-
and positive-pressure ventilation [eg, bag and mask with scribed for moderate sedation. Vital signs, including ox-
oxygen capacity as described previously]). The patient’s ygen saturation and heart rate, must be documented at
vital signs should be recorded at specific intervals. If the least every 5 minutes in a time-based record. The use of
patient is not fully alert, oxygen saturation and heart a precordial stethoscope or capnograph for patients who
rate monitoring shall be used continuously until appro- are difficult to observe (eg, during MRI or in a darkened
priate discharge criteria are met (see Appendix 2). Be- room) to aid in monitoring adequacy of ventilation is
cause sedation medications with a long half-life may encouraged.143 The practitioner shall document the
delay the patient’s complete return to baseline or pose name, route, site, time of administration, and dosage of
the risk of resedation, some patients might benefit from all drugs administered. The inspired concentrations of
a longer period of less-intense observation (eg, a step- inhalation sedation agents and oxygen and the duration
down observation area in which multiple patients can be of administration shall be documented.
observed simultaneously) before discharge from medical
supervision (see also “Documentation” for instructions Postsedation Care
to families).45,103,131,132 A recently described and simple The facility and procedures followed for postsedation
evaluation tool may be the ability of the infant or child care shall conform to those described for moderate se-
to remain awake for at least 20 minutes when placed in dation.
a quiet environment.100 Patients who have received re-
versal agents, such as flumazenil or naloxone, will also
SPECIAL CONSIDERATIONS
require a longer period of observation, because the du-
ration of the drugs administered may exceed the dura- Local Anesthetic Agents
tion of the antagonist, which can lead to resedation. All local anesthetic agents are cardiac depressants and
may cause central nervous system excitation or depres-
Deep Sedation sion. Particular attention should be paid to dosage in
Deep sedation is a drug-induced depression of con- small children.64,66 To ensure that the patient will not
sciousness during which patients cannot be easily receive an excessive dose, the maximum allowable safe
aroused but respond purposefully after repeated verbal dosage (eg, mg/kg) should be calculated before admin-
or painful stimulation (see “Definition of Terms Used in istration. There may be enhanced sedative effects when
This Report”). The state and risks of deep sedation may the highest recommended doses of local anesthetic drugs
be indistinguishable from those of general anesthesia. are used in combination with other sedatives or narcot-
ics (see Tables 2 and 3 for limits and conversion tables of
Personnel commonly used local anesthetics).64,144–157 In general,
There must be 1 person available whose only responsi- when administering local anesthetic drugs, the practitio-
bility is to constantly observe the patient’s vital signs, ner should aspirate frequently to minimize the likeli-
airway patency, and adequacy of ventilation and to ei- hood that the needle is in a blood vessel; lower doses
ther administer drugs or direct their administration. At should be used when injecting into vascular tissues.158
2594 AMERICAN ACADEMY OF PEDIATRICS
Downloaded from www.aappublications.org/news by guest on February 22, 2020TABLE 2 Commonly Used Local Anesthetic Agents: Doses, TABLE 3 Local Anesthetic Percent Concentration: Conversion to
Duration, and Calculations mg/mL
Local Anesthetic Maximum Dose With Duration of Action, Concentration, % mg/mL
Epinephrine, mg/kga minb 3.0 30.0
Medical Dental 2.5 25.0
2.0 20.0
Esters
1.0 10.0
Procaine 10.0 6 60–90
0.5 5.0
Chloroprocaine 20.0 12 30–60
0.25 2.5
Tetracaine 1.5 1 180–600
0.125 1.25
Amides
Lidocaine 7.0 4.4 90–200
Mepivacaine 7.0 4.4 120–240
Bupivacaine 3.0 1.3 180–600 endotracheal intubation is required for more pro-
Levobupivacaine 3.0 2 180–600 longed ventilatory support. In addition to standard
Ropivacaine 3.0 2 180–600 endotracheal intubation techniques, a number of new
Articaine 7 60–230 devices are available for the management of patients
Maximum recommended doses and duration of action are shown. Note that lower doses with abnormal airway anatomy or airway obstruction.
should be used in very vascular areas.
a These are maximum doses of local anesthetics combined with epinephrine; lower doses are Examples include the laryngeal mask airway (LMA),
recommended when used without epinephrine. Doses of amides should be decreased by 30% the cuffed oropharyngeal airway, and a variety of kits
for infants younger than 6 months. When lidocaine is being administered intravascularly (eg, to perform an emergency cricothyrotomy.
during intravenous regional anesthesia), the dose should be decreased to 3 to 5 mg/kg; long-
acting local anesthetic agents should not be used for intravenous regional anesthesia. The largest clinical experience in pediatrics is with the
b Duration of action depends on concentration, total dose, and site of administration; use of LMA, which is available in a variety of sizes and can
epinephrine; and the patient’s age. even be used in neonates. Use of the LMA is now being
introduced into advanced airway training courses, and
Pulse Oximetry familiarity with insertion techniques can be life-sav-
The new-generation pulse oximeters are less susceptible to ing.174,175 The LMA can also serve as a bridge to secure
motion artifacts and may be more useful than older oxime- airway management in children with anatomic airway
ters that do not contain the updated software.159–163 Oxime- abnormalities.176,177 Practitioners are encouraged to gain
ters that change tone with changes in hemoglobin satura- experience with these techniques as they become incor-
tion provide immediate aural warning to everyone within porated into pediatric advanced life support courses.
hearing distance. It is essential that any oximeter probe is An additional emergency device with which to become
properly positioned; clip-on devices are prone to easy dis- familiar is the intraosseous needle. Intraosseous needles are
placement, which may produce artifactual data (underes- also available in several sizes and can be life-saving in the
timation or overestimation of oxygen saturation).141,142 rare situation when rapid establishment of intravenous
access is not possible. Familiarity with the use of these
Capnography adjuncts for the management of emergencies can be ob-
Expired carbon dioxide monitoring is valuable to diag- tained by keeping current with resuscitation courses, such
nose the simple presence or absence of respirations, as Pediatric Advanced Life Support and Advanced Pediatric
airway obstruction, or respiratory depression, particu- Life Support or other approved programs.
larly in patients sedated in less-accessible locations, such
as MRI or computerized axial tomography devices or Patient Simulators
darkened rooms.47,49,50,143,164–173 The use of expired carbon Advances in technology, particularly patient simulators
dioxide monitoring devices is encouraged for sedated that allow a variety of programmed adverse events such as
children, particularly in situations where other means of apnea, bronchospasm, laryngospasm, response to medical
assessing the adequacy of ventilation are limited. Several interventions, and printouts of physiologic parameters, are
manufacturers have produced nasal cannulae that allow now available. The use of such devices is encouraged to
simultaneous delivery of oxygen and measurement of better train medical professionals to respond more appro-
expired carbon dioxide values.164,165 Although these de- priately and effectively to rare events.178–180
vices can have a high degree of false-positive alarms,
they are also very accurate for the detection of complete Monitoring During MRI
airway obstruction or apnea.166,168,173 The powerful magnetic field and the generation of radio
frequency emissions necessitate the use of special equip-
Adjuncts to Airway Management and Resuscitation ment to provide continuous patient monitoring
The vast majority of sedation complications can be throughout the MRI procedure. Pulse oximeters capable
managed with simple maneuvers, such as providing of continuous function during scanning should be used
supplemental oxygen, opening the airway, suctioning, in any sedated or restrained pediatric patient. Thermal
and using bag-mask-valve ventilation. Occasionally, injuries can result if appropriate precautions are not
PEDIATRICS Volume 118, Number 6, December 2006 2595
Downloaded from www.aappublications.org/news by guest on February 22, 2020taken; avoid coiling the oximeter wire and place the STAFF
probe as far from the magnetic coil as possible to dimin- Raymond J. Koteras, MHA
ish the possibility of injury. Electrocardiogram monitor-
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