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## Complete Summary

#### GUIDELINE TITLE

Guidelines for monitoring and management of pediatric patients during
and after sedation for diagnostic and therapeutic procedures: an update.

#### BIBLIOGRAPHIC SOURCE(S)

American Academy of Pediatrics, American Academy of Pediatric Dentistry,
Cote CJ, Wilson S, Work Group on Sedation. Guidelines for monitoring and
management of pediatric patients during and after sedation for
diagnostic and therapeutic procedures: an update. Pediatrics 2006
Dec;118(6):2587-602. \[213 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17142550)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Academy of
Pediatrics (AAP). Guidelines for monitoring and management of pediatric
patients during and after sedation for diagnostic and therapeutic
procedures. Pediatrics 1992 Jun;89(6 Pt 1):1110-5.

Guidelines for monitoring and management of pediatric patients during
and after sedation for diagnostic and therapeutic procedures: addendum.
Pediatrics 2002 Oct;110(4):836-8.

All clinical reports and policy statements from the American Academy of
Pediatrics automatically expire 5 years after publication unless
reaffirmed, revised, or retired at or before that time.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Conditions requiring elective and emergency use of sedative agents in
nontraditional settings

#### GUIDELINE CATEGORY

Evaluation\
Management

#### CLINICAL SPECIALTY

Anesthesiology\
Dentistry\
Pediatrics

#### INTENDED USERS

Dentists\
Physicians

#### GUIDELINE OBJECTIVE(S)

To unify the guidelines for sedation used by medical and dental
practitioners, add clarifications regarding monitoring modalities,
provide new information from medical and dental literature, and suggest
methods for further improvement in safety and outcomes

#### TARGET POPULATION

Pediatric patients undergoing elective and emergency procedures
requiring the use of sedative and general anesthetic agents in any
surgical setting

#### INTERVENTIONS AND PRACTICES CONSIDERED

Monitoring and documentation performed during and after a procedure for
children receiving sedatives and general anesthetic agents

#### MAJOR OUTCOMES CONSIDERED

Morbidity and mortality associated with the use of sedative and general
anesthetic agents in the nontraditional surgical setting

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**[General Guidelines]{.underline}**

**Candidates**

Patients who are in American Society of Anesthesiologists (ASA) classes
I and II (see Appendix 1 in the original guideline document) are
frequently considered appropriate candidates for minimal, moderate, or
deep sedation. Children in ASA classes III and IV, children with special
needs, and those with anatomic airway abnormalities or extreme tonsillar
hypertrophy present issues that require additional and individual
consideration, particularly for moderate and deep sedation (Malviya,
Voepel-Lewis, & Tait, 1997). Practitioners are encouraged to consult
with appropriate subspecialists and/or an anesthesiologist for patients
at increased risk of experiencing adverse sedation events because of
their underlying medical/ surgical conditions.

**Responsible Person**

The pediatric patient shall be accompanied to and from the treatment
facility by a parent, legal guardian, or other responsible person. It is
preferable to have 2 or more adults accompany children who are still in
car safety seats if transportation to and from a treatment facility is
provided by one of the adults (Bull et al., 1999).

**Facilities**

The practitioner who uses sedation must have immediately available
facilities, personnel, and equipment to manage emergency and rescue
situations. The most common serious complications of sedation involve
compromise of the airway or depressed respirations resulting in airway
obstruction, hypoventilation, hypoxemia, and apnea. Hypotension and
cardiopulmonary arrest may occur, usually from inadequate recognition
and treatment of respiratory compromise. Other rare complications may
also include seizures and allergic reactions. Facilities that provide
pediatric sedation should monitor for, and be prepared to treat, such
complications.

**Back-up Emergency Services**

A protocol for access to back-up emergency services shall be clearly
identified with an outline of the procedures necessary for immediate
use. For nonhospital facilities, a protocol for ready access to
ambulance service and immediate activation of the Emergency Medical
Services (EMS) system for life-threatening complications must be
established and maintained. It should be understood that the
availability of EMS services does not replace the practitioner\'s
responsibility to provide initial rescue in managing life-threatening
complications.

**On-Site Monitoring and Rescue Equipment**

An emergency cart or kit must be immediately accessible. This cart or
kit must contain equipment to provide the necessary age- and
size-appropriate drugs and equipment to resuscitate a nonbreathing and
unconscious child. The contents of the kit must allow for the provision
of continuous life support while the patient is being transported to a
medical facility or to another area within a medical facility. All
equipment and drugs must be checked and maintained on a scheduled basis
(see Appendices 3 and 4 in the original guideline document for suggested
drugs and emergency life support equipment to consider before the need
for rescue occurs). Monitoring devices, such as electrocardiography
(ECG) machines, pulse oximeters (with size appropriate oximeter probes),
end-tidal carbon dioxide monitors, and defibrillators (with
size-appropriate defibrillator paddles), must have a safety and function
check on a regular basis as required by local or state regulation.

**Documentation**

Documentation before sedation shall include, but not be limited to, the
guidelines that follow.

1.  Informed consent: the patient record shall document that appropriate
    informed consent was obtained according to local, state, and
    institutional requirements (\"Informed consent,\" 1995)

2.  Instructions and information provided to the responsible person: the
    practitioner shall provide verbal and/or written instructions to the
    responsible person. Information shall include objectives of the
    sedation and anticipated changes in behavior during and after
    sedation. Special instructions shall be given to the responsible
    adult for infants and toddlers who will be transported home in a car
    safety seat regarding the need to carefully observe the child\'s
    head position to avoid airway obstruction. Transportation in a car
    safety seat poses a particular risk for infants who have received
    medications known to have a long half-life, such as chloral hydrate,
    intramuscular pentobarbital, or phenothiazine (Cote, Karl, et al.,
    2000; Cote, Notterman, et al., 2000; Malviya et al., 2004; Malviya
    et al., \"Prolonged recovery,\" 2000). Consideration for a longer
    period of observation shall be given if the responsible person\'s
    ability to observe the child is limited (e.g., only 1 adult who also
    has to drive). Another indication for prolonged observation would be
    a child with an anatomic airway problem or a severe underlying
    medical condition. A 24-hour telephone number for the practitioner
    or his or her associates shall be provided to all patients and their
    families. Instructions shall include limitations of activities and
    appropriate dietary precautions.

**Dietary Precautions**

Agents used for sedation have the potential to impair protective airway
reflexes, particularly during deep sedation. Although a rare occurrence,
pulmonary aspiration may occur if the child regurgitates and cannot
protect his or her airway. Therefore, it is prudent that, before
sedation, the practitioner evaluate preceding food and fluid intake. It
is likely that the risk of aspiration during procedural sedation differs
from that during general anesthesia involving tracheal intubation or
other airway manipulation (Babl et al., 2005; Roback et al., 2004).
However, because the absolute risk of aspiration during procedural
sedation is not yet known, guidelines for fasting periods before
elective sedation should generally follow those used for elective
general anesthesia. For emergency procedures in children who have not
fasted, the risks of sedation and the possibility of aspiration must be
balanced against the benefits of performing the procedure promptly (see
below). Additional research is needed to better elucidate the
relationships between various fasting intervals and sedation
complications.

*Before Elective Sedation*

Children receiving sedation for elective procedures should generally
follow the same fasting guidelines as those for general anesthesia (see
Table below titled \"Appropriate Intake of Food and Liquids Before
Elective Sedation\"). It is permissible for routine necessary
medications to be taken with a sip of water on the day of the procedure.

+----------------------------------------------------------+-----------+
| **Table. Appropriate Intake of Food and Liquid Before    |           |
| Elective Sedation**                                      |           |
+==========================================================+===========+
| **Ingested Material**                                    | **Minimum |
|                                                          | Fasting   |
|                                                          | Period,   |
|                                                          | hours**   |
+----------------------------------------------------------+-----------+
| -   Clear liquids: water, fruit juices without pulp,     | 2         |
|     carbonated beverages, clear tea, black coffee        |           |
+----------------------------------------------------------+-----------+
| -   Breast milk                                          | 4         |
+----------------------------------------------------------+-----------+
| -   Infant formula                                       | 6         |
+----------------------------------------------------------+-----------+
| -   Nonhuman milk: because nonhuman milk is similar to   | 6         |
|     solids in gastric emptying time, the amount ingested |           |
|     must be considered when determining an appropriate   |           |
|     fasting period                                       |           |
+----------------------------------------------------------+-----------+
| -   Light meal: a light meal typically consists of toast | 6         |
|     and clear liquids. Meals that include fried or fatty |           |
|     foods or meat may prolong gastric emptying time;     |           |
|     both the amount and type of foods ingested must be   |           |
|     considered when determining an appropriate fasting   |           |
|     period                                               |           |
+----------------------------------------------------------+-----------+

*Before Emergency Sedation*

The practitioner must always balance the possible risks of sedating
nonfasted patients with the benefits and necessity for completing the
procedure. In this circumstance, the use of sedation must be preceded by
an evaluation of food and fluid intake. There are few published studies
with adequate statistical power to provide guidance to the practitioner
regarding safety or risk of pulmonary aspiration of gastric contents
during procedural sedation (Babl et al., 2005; Roback et al., 2004;
Agrawal et al., 2003; Green, 2003; Green & Krauss, 2002; Treston, 2004).
When protective airway reflexes are lost, gastric contents may be
regurgitated into the airway. Therefore, patients with a history of
recent oral intake or with other known risk factors, such as trauma,
decreased level of consciousness, extreme obesity, pregnancy, or bowel
motility dysfunction, require careful evaluation before administration
of sedatives. When proper fasting has not been ensured, the increased
risks of sedation must be carefully weighed against its benefits, and
the lightest effective sedation should be used. The use of agents with
less risk of depressing protective airway reflexes may be preferred
(Green & Krauss, 2004). Some emergency patients requiring deep sedation
may require protection of the airway before sedation.

**Use of Immobilization Devices**

Immobilization devices such as papoose boards must be applied in such a
way as to avoid airway obstruction or chest restriction. The child\'s
head position and respiratory excursions should be checked frequently to
ensure airway patency. If an immobilization device is used, a hand or
foot should be kept exposed, and the child should never be left
unattended. If sedating medications are administered in conjunction with
an immobilization device, monitoring must be used at a level consistent
with the level of sedation achieved.

*Documentation at the Time of Sedation*

1.  Health evaluation: before sedation, a health evaluation shall be
    performed by an appropriately licensed  practitioner and reviewed by
    the sedation team at the time of treatment for possible interval
    changes. The purpose of this evaluation is to not only document
    baseline status but also determine if patients present specific risk
    factors that may warrant additional consultation before sedation.
    This evaluation will also screen out patients whose sedation will
    require more advanced airway or cardiovascular management skills or
    alterations in the doses or types of medications used for procedural
    sedation.

> A new concern for the practitioner is the widespread use of
> medications that may interfere with drug absorption or metabolism and,
> therefore, enhance or shorten the effect time of sedating medications.
> Herbal medicines (e.g., St John\'s wort or echinacea) may alter drug
> pharmacokinetics through inhibition of the cytochrome P450 system,
> resulting in prolonged drug effect and altered (increased or
> decreased) blood drug concentrations (Gorski et al., 2004; Hall et
> al., 2003; Markowitz et al., 2003; Spinella, 2001; Wang et al., 2001;
> Xie & Kim, 2005). Kava may increase the effects of sedatives by
> potentiating gamma-aminobutyric acid inhibitory neurotransmission, and
> valerian may itself produce sedation that apparently is mediated
> through modulation of gamma-aminobutyric acid neurotransmission and
> receptor function (Ang-Lee, Moss, & Yuan, 2001; Abebe, 2002). Drugs
> such as erythromycin, cimetidine, and others may also inhibit the
> cytochrome P450 system, resulting in prolonged sedation with midazolam
> as well as other medications competing for the same enzyme systems
> (von Rosensteil & Adam, 1995; Hiller et al., 1990; Mattila et al.,
> 1993; Olkkola et al., 1993). Medications used to treat human
> immunodeficiency virus (HIV) infection, some anticonvulsants, and some
> psychotropic medications may also produce clinically important
> drug-drug interactions (Flockhart & Oesterheld, 2000; Yuan, Flockhart,
> & Balian, 1999; Young, 2005). Therefore, carefully obtaining a drug
> history is a vital part of the safe sedation of children. The
> clinician should consult various sources (a pharmacist, textbooks,
> online services, or handheld databases) for specific information on
> drug interactions (Wilkinson, 2005).
>
> The health evaluation should include:

-   Obtaining age and weight

-   Obtaining a health history, including (1) allergies and previous
    allergic or adverse drug reactions; (2) medication/drug history,
    including dosage, time, route, and site of administration for
    prescription, over-the-counter, herbal, or illicit drugs; (3)
    relevant diseases, physical abnormalities, and neurologic impairment
    that might increase the potential for airway obstruction, such as a
    history of snoring or obstructive sleep apnea (American Academy of
    Pediatrics, Subcommittee on Obstructive Sleep Apnea Syndrome &
    Section on Pediatric Pulmonology, 2002; Schechter, 2002); (4)
    pregnancy status; (5) a summary of previous relevant
    hospitalizations; (6) history of sedation or general anesthesia and
    any complications or unexpected responses; and (7) relevant family
    history, particularly that related to anesthesia

-   A review of systems with a special focus on abnormalities of
    cardiac, pulmonary, renal, or hepatic function that might alter the
    child\'s expected responses to sedating/analgesic medications

-   Determination of vital signs, including heart rate, blood pressure,
    respiratory rate, and temperature (for some children who are very
    upset or noncooperative, this may not be possible, and a note should
    be written to document this occurrence)

-   A physical examination, including a focused evaluation of the airway
    (tonsillar hypertrophy, abnormal anatomy \[e.g., mandibular
    hypoplasia\]) to determine if there is an increased risk of airway
    obstruction (Hoffman et al., 2002; Litman et al., \"Upper airway
    obstruction,\" 1998; Fishbaugh et al., 1997).

-   A physical status evaluation (ASA classification \[see Appendix 1 in
    the original guideline document\])

-   Obtaining name, address, and telephone number of the child\'s
    medical home

> For hospitalized patients, the current hospital record may suffice for
> adequate documentation of presedation health; however, a brief note
> shall be written documenting that the chart was reviewed, positive
> findings were noted, and a management plan was formulated. If the
> clinical or emergency condition of the patient precludes acquiring
> complete information before sedation, this health evaluation should be
> obtained as soon as is feasible.

2.  Prescriptions: when prescriptions are used for sedation, a copy of
    the prescription or a note describing the content of the
    prescription should be in the patient\'s chart along with a
    description of the instructions that were given to the responsible
    person. *Prescription medications intended to accomplish procedural
    sedation must not be administered without the benefit of direct
    supervision by trained medical personnel*. Administration of
    sedating medications at home poses an unacceptable risk,
    particularly for infants and preschool- aged children traveling in
    car safety seats (Cote, Notterman et al., 2000).

*Documentation During Treatment*

The patient\'s chart shall contain a time-based record that includes the
name, route, site, time, dosage, and patient effect of administered
drugs. Before sedation, a \"time out\" should be performed to confirm
the patient\'s name, procedure to be performed, and site of the
procedure (Joint Commission on Accreditation of Healthcare
Organizations, 2005). During administration, the inspired concentrations
of oxygen and inhalation sedation agents and the duration of their
administration shall be documented. Before drug administrations, special
attention must be paid to calculation of dosage (i.e., mg/kg). The
patient\'s chart shall contain documentation at the time of treatment
that the patient\'s level of consciousness and responsiveness, heart
rate, blood pressure, respiratory rate, and oxygen saturation were
monitored until the patient attained predetermined discharge criteria
(see Appendix 2 of the original guideline document). A variety of
sedation-scoring systems are available and may aid this process (Malviya
et al., 2002; Malviya et al., 2004). Adverse events and their treatment
shall be documented.

*Documentation After Treatment*

The time and condition of the child at discharge from the treatment area
or facility shall be documented; this should include documentation that
the child\'s level of consciousness and oxygen saturation in room air
have returned to a state that is safe for discharge by recognized
criteria (see Appendix 2 in the original guideline document). Patients
receiving supplemental oxygen before the procedure should have a similar
oxygen need after the procedure. Because some sedation medications are
known to have a long half-life and may delay a patient\'s complete
return to baseline or pose the risk of resedation (Cote, Karl et al.,
2000; Malviya et al., \"Prolonged recovery,\" 2000; Mayers et al., 1991;
Terndrup et al., 1991), some patients might benefit from a longer period
of less-intense observation (e.g., a step-down observation area) before
discharge from medical supervision (Cote, 2004). Several scales to
evaluate recovery have been devised and validated (Malviya et al., 2002;
Macnab et al., 1991; Chernik et al., 1990). A recently described and
simple evaluation tool may be the ability of the infant or child to
remain awake for at least 20 minutes when placed in a quiet environment
(Malviya et al., 2004).

**[Continuous Quality Improvement]{.underline}**

The essence of medical error reduction is a careful examination of index
events and root-cause analysis of how the event could be avoided in the
future (Bagian et al., 2001; May & Aulisio, 2001; Kazandjian, 2002;
Connor, Ponte, & Conway, 2002; Gosbee, 2002). Therefore, each facility
should maintain records that track adverse events such as desaturation,
apnea, laryngospasm, the need for airway interventions including jaw
thrust or positive pressure ventilation, prolonged sedation,
unanticipated use of reversal agents, unintended or prolonged hospital
admission, and unsatisfactory sedation/analgesia/anxiolysis. Such events
can then be examined for assessment of risk reduction and improvement in
patient satisfaction.

**[Preparation And Setup For Sedation Procedures]{.underline}**

Part of the safety net of sedation is to use a systematic approach so as
to not overlook having an important drug, piece of equipment, or monitor
immediately available at the time of a developing emergency. To avoid
this problem, it is helpful to use an acronym that allows the same setup
and checklist for every procedure. A commonly used acronym that is
useful in planning and preparation for a procedure is SOAPME:

**S** (suction)---size-appropriate suction catheters and a functioning
suction apparatus (e.g., Yankauer-type suction)

**O** (oxygen)---adequate oxygen supply and functioning flow
meters/other devices to allow its delivery

**A** (airway)---size-appropriate airway equipment (nasopharyngeal and
oropharyngeal airways, laryngoscope blades \[checked and functioning\],
endotracheal tubes, stylets, face mask, bag-valve-mask or equivalent
device \[functioning\])

**P** (pharmacy)---all the basic drugs needed to support life during an
emergency, including antagonists as indicated

**M** (monitors)---functioning pulse oximeter with size-appropriate
oximeter probes (Barker et al., 1993; Kelleher & Ruff, 1989) and other
monitors as appropriate for the procedure (e.g., noninvasive blood
pressure, end-tidal carbon dioxide, electrocardiogram \[ECG\],
stethoscope)

**E** (equipment)---special equipment or drugs for a particular case
(e.g., defibrillator)

**[Specific Guidelines For Intended Level of Sedation]{.underline}**

**Minimal Sedation**

Minimal sedation (formerly anxiolysis) is a drug-induced state during
which patients respond normally to verbal commands. Although cognitive
function and coordination may be impaired, ventilatory and
cardiovascular functions are unaffected. Children who have received
minimal sedation generally will not require more than observation and
intermittent assessment of their level of sedation. Some children will
become moderately sedated despite the intended level of minimal
sedation; should this occur, the guidelines for moderate sedation will
apply (Dial et al., 2001).

**Moderate Sedation**

Moderate sedation (formerly conscious sedation or sedation/analgesia) is
a drug-induced depression of consciousness during which patients respond
purposefully to verbal commands or light tactile stimulation (see
\"Definition of Terms Used in This Report\" in the original guideline
document). No interventions are required to maintain a patent airway,
and spontaneous ventilation is adequate. Cardiovascular function is
usually maintained. The caveat that loss of consciousness should be
unlikely is a particularly important aspect of the definition of
moderate sedation. The drugs and techniques used should carry a margin
of safety wide enough to render unintended loss of consciousness highly
unlikely. Because the patient who receives moderate sedation may
progress into a state of deep sedation and obtundation, the practitioner
should be prepared to increase the level of vigilance corresponding to
what is necessary for deep sedation (Dial et al., 2001).

*Personnel*

[The Practitioner]{.underline}

The practitioner responsible for the treatment of the patient and/or the
administration of drugs for sedation must be competent to use such
techniques, provide the level of monitoring provided in these
guidelines, and manage complications of these techniques (i.e., to be
able to rescue the patient). Because the level of intended sedation may
be exceeded, the practitioner must be sufficiently skilled to provide
rescue should the child progress to a level of deep sedation. The
practitioner must be trained in, and capable of providing, at the
minimum, bag-valve-mask ventilation to be able to oxygenate a child who
develops airway obstruction or apnea. Training in, and maintenance of,
advanced pediatric airway skills is required; regular skills
reinforcement is strongly encouraged.

[Support Personnel]{.underline}

The use of moderate sedation shall include provision of a person, in
addition to the practitioner, whose responsibility is to monitor
appropriate physiologic parameters and to assist in any supportive or
resuscitation measures if required. This individual may also be
responsible for assisting with interruptible patient-related tasks of
short duration (American Society of Anesthesiologists, 2002). This
individual must be trained in and capable of providing pediatric basic
life support. The support person shall have specific assignments in the
event of an emergency and current knowledge of the emergency cart
inventory. The practitioner and all ancillary personnel should
participate in periodic reviews and practice drills of the facility\'s
emergency protocol to ensure proper function of the equipment and
coordination of staff roles in such emergencies.

*Monitoring and Documentation*

[Baseline]{.underline}

Before administration of sedative medications, a baseline determination
of vital signs shall be documented. For some children who are very upset
or noncooperative, this may not be possible, and a note should be
written to document this happenstance.

[During the Procedure]{.underline}

The practitioner shall document the name, route, site, time of
administration, and dosage of all drugs administered. There shall be
continuous monitoring of oxygen saturation and heart rate and
intermittent recording of respiratory rate and blood pressure; these
should be recorded in a time-based record. Restraining devices should be
checked to prevent airway obstruction or chest restriction. If a
restraint device is used, a hand or foot should be kept exposed. The
child\'s head position should be checked frequently to ensure airway
patency. A functioning suction apparatus must be present.

[After the Procedure]{.underline}

The child who has received moderate sedation must be observed in a
suitably equipped recovery facility (i.e., the facility must have
functioning suction apparatus as well as the capacity to deliver more
than 90% oxygen and positive-pressure ventilation \[e.g., bag and mask
with oxygen capacity as described previously\]). The patient\'s vital
signs should be recorded at specific intervals. If the patient is not
fully alert, oxygen saturation and heart rate monitoring shall be used
continuously until appropriate discharge criteria are met (see Appendix
2 in the original guideline document). Because sedation medications with
a long half-life may delay the patient\'s complete return to baseline or
pose the risk of resedation, some patients might benefit from a longer
period of less-intense observation (e.g., a stepdown observation area in
which multiple patients can be observed simultaneously) before discharge
from medical supervision (see also \"Documentation\" for instructions to
families \[Cote, Karl et al., 2000; Malviya et al., \"Prolonged
recovery,\" 2000; Mayers et al., 1991; Terndrup et al., 1991\]). A
recently described and simple evaluation tool may be the ability of the
infant or child to remain awake for at least 20 minutes when placed in a
quiet environment (Malviya et al., 2004). Patients who have received
reversal agents, such as flumazenil or naloxone, will also require a
longer period of observation, because the duration of the drugs
administered may exceed the duration of the antagonist, which can lead
to resedation.

**Deep Sedation**

Deep sedation is a drug-induced depression of consciousness during which
patients cannot be easily aroused but respond purposefully after
repeated verbal or painful stimulation (see \"Definition of Terms Used
in This Report\" in the original guideline document). The state and
risks of deep sedation may be indistinguishable from those of general
anesthesia.

*Personnel*

There must be 1 person available whose only responsibility is to
constantly observe the patient\'s vital signs, airway patency, and
adequacy of ventilation and to either administer drugs or direct their
administration. At least 1 individual must be present who is trained in,
and capable of, providing advanced pediatric life support and who is
skilled in airway management and cardiopulmonary resuscitation; training
in pediatric advanced life support is required.

*Equipment*

In addition to the equipment previously cited for moderate sedation, an
ECG monitor and a defibrillator for use in pediatric patients should be
readily available.

*Vascular Access*

Patients receiving deep sedation should have an intravenous line placed
at the start of the procedure or have a person skilled in establishing
vascular access in pediatric patients immediately available.

*Monitoring*

A competent individual shall observe the patient continuously. The
monitoring shall include all parameters described for moderate sedation.
Vital signs, including oxygen saturation and heart rate, must be
documented at least every 5 minutes in a time-based record. The use of a
precordial stethoscope or capnograph for patients who are difficult to
observe (e.g., during magnetic resonance imaging (MRI) or in a darkened
room) to aid in monitoring adequacy of ventilation is encouraged (Hart
et al., 1997). The practitioner shall document the name, route, site,
time of administration, and dosage of all drugs administered. The
inspired concentrations of inhalation sedation agents and oxygen and the
duration of administration shall be documented.

*Postsedation Care*

The facility and procedures followed for postsedation care shall conform
to those described for moderate sedation.

**[Special Considerations]{.underline}**

**Local Anesthetic Agents**

All local anesthetic agents are cardiac depressants and may cause
central nervous system excitation or depression. Particular attention
should be paid to dosage in small children (Goodson & Moore, 1983;
Jastak & Peskin, 1991). To ensure that the patient will not receive an
excessive dose, the maximum allowable safe dosage (e.g., mg/kg) should
be calculated before administration. There may be enhanced sedative
effects when the highest recommended doses of local anesthetic drugs are
used in combination with other sedatives or narcotics (see Tables 2 and
3 in the original guideline document for limits and conversion tables of
commonly used local anesthetics) (Goodson & Moore, 1983; Aubuchon, 1982;
Fitzmaurice et al., 1990; Tipton et al., 1989; Gunter, 2002; Resar &
Helfaer, 1998; Yagiela, 2004; Haas, 2002; Malamed, \"Local anesthetic,\"
2004; Malamed, \"The needle,\" 2004; Malamed, \"Clinical action,\" 2004;
Ram & Amir, 2006; Jakobs et al., 1995; Wright et al., 1989; Malamed,
Gagnon, & Leblanc, 2000). In general, when administering local
anesthetic drugs, the practitioner should aspirate frequently to
minimize the likelihood that the needle is in a blood vessel; lower
doses should be used when injecting into vascular tissues (American
Academy of Pediatric Dentistry Council on Clinical Affairs, \"Guideline
on appropriate use of local anesthesia,\" 2005).

**Pulse Oximetry**

The new-generation pulse oximeters are less susceptible to motion
artifacts and may be more useful than older oximeters that do not
contain the updated software (Next-generation pulse oximetry, 2003;
Barker, 2002; Malviya et al., \"False alarms,\" 2000; Barker & Shah,
1996; Barker & Shah, 1997). Oximeters that change tone with changes in
hemoglobin saturation provide immediate aural warning to everyone within
hearing distance. It is essential that any oximeter probe is properly
positioned; clip-on devices are prone to easy displacement, which may
produce artifactual data (underestimation or overestimation of oxygen
saturation) (Barker et al., 1993; Kelleher & Ruff, 1989).

**Capnography**

Expired carbon dioxide monitoring is valuable to diagnose the simple
presence or absence of respirations, airway obstruction, or respiratory
depression, particularly in patients sedated in less-accessible
locations, such as MRI or computerized axial tomography devices or
darkened rooms (Kim et al., 2003; Mason et al., 2000; McQuillen &
Steele, 2000; Hart et al., 1997; Colman & Krauss, 1999; Wright, 1992;
Croswell et al., 1995; Tobias, 1999; Primosch, Buzzi, & Jerrell, 2000;
Roelofse, 2000; Wilson et al., 1996; Miner, Heegaard, & Plummer, 2002;
Vascello & Bowe, 1999; Iwasaki et al., 1989). The use of expired carbon
dioxide monitoring devices is encouraged for sedated children,
particularly in situations where other means of assessing the adequacy
of ventilation are limited. Several manufacturers have produced nasal
cannulae that allow simultaneous delivery of oxygen and measurement of
expired carbon dioxide values (Colman & Krauss, 1999; Wright, 1992).
Although these devices can have a high degree of false-positive alarms,
they are also very accurate for the detection of complete airway
obstruction or apnea (Croswell et al., 1995; Primosch, Buzzi, & Jerrell,
2000; Iwasaki et al., 1989).

**Adjuncts to Airway Management and Resuscitation**

The vast majority of sedation complications can be managed with simple
maneuvers, such as providing supplemental oxygen, opening the airway,
suctioning, and using bag-mask-valve ventilation. Occasionally,
endotracheal intubation is required for more prolonged ventilatory
support. In addition to standard endotracheal intubation techniques, a
number of new devices are available for the management of patients with
abnormal airway anatomy or airway obstruction. Examples include the
laryngeal mask airway (LMA), the cuffed oropharyngeal airway, and a
variety of kits to perform an emergency cricothyrotomy.

The largest clinical experience in pediatrics is with the LMA, which is
available in a variety of sizes and can even be used in neonates. Use of
the LMA is now being introduced into advanced airway training courses,
and familiarity with insertion techniques can be life-saving. (Berry,
Brimacombe, & Verghese, 1998; Patterson, 1999). The LMA can also serve
as a bridge to secure airway management in children with anatomic airway
abnormalities (Selim, et al., 1999; Munro, Butler, & Washington, 1997).
Practitioners are encouraged to gain experience with these techniques as
they become incorporated into pediatric advanced life support courses.

An additional emergency device with which to become familiar is the
intraosseous needle. Intraosseous needles are also available in several
sizes and can be life-saving in the rare situation when rapid
establishment of intravenous access is not possible. Familiarity with
the use of these adjuncts for the management of emergencies can be
obtained by keeping current with resuscitation courses, such as
Pediatric Advanced Life Support and Advanced Pediatric Life Support or
other approved programs.

**Patient Simulators**

Advances in technology, particularly patient simulators that allow a
variety of programmed adverse events such as apnea, bronchospasm,
laryngospasm, response to medical interventions, and printouts of
physiologic parameters, are now available. The use of such devices is
encouraged to better train medical professionals to respond more
appropriately and effectively to rare events (Rowe & Cohen, 2002;
Medina, Racadio, & Schwid, 2000; Blike, Cravero, & Nelson, 2001)

**Monitoring During MRI**

The powerful magnetic field and the generation of radio frequency
emissions necessitate the use of special equipment to provide continuous
patient monitoring throughout the MRI procedure. Pulse oximeters capable
of continuous function during scanning should be used in any sedated or
restrained pediatric patient. Thermal injuries can result if appropriate
precautions are not taken; avoid coiling the oximeter wire and place the
probe as far from the magnetic coil as possible to diminish the
possibility of injury. Electrocardiogram monitoring during MRI has been
associated with thermal injury; special MRI-compatible ECG pads are
essential to allow safe monitoring (Kanal, Shellock, & Talagala, 1990;
Shellock & Kanal, 1996; Shellock, 2002; Dempsey, Condon, & Hadley,
2002). Expired carbon dioxide monitoring is strongly encouraged in this
setting.

**Nitrous Oxide**

Inhalation sedation/analgesia equipment that delivers nitrous oxide must
have the capacity of delivering 100% and never less than 25% oxygen
concentration at a flow rate appropriate to the size of the patient.
Equipment that delivers variable ratios of nitrous oxide to oxygen and
that has a delivery system that covers the mouth and nose must be used
in conjunction with a calibrated and functional oxygen analyzer. All
nitrous oxide-to-oxygen inhalation devices should be calibrated in
accordance with appropriate state and local requirements. Consideration
should be given to the National Institute of Occupational Safety and
Health Standards for the scavenging of waste gases (National Institute
for Occupational Safety and Health, 1977). Newly constructed or
reconstructed treatment facilities, especially those with piped-in
nitrous oxide and oxygen, must have appropriate state or local
inspections to certify proper function of inhalation sedation/analgesia
systems before any delivery of patient care.

Nitrous oxide in oxygen with varying concentrations has been
successfully used for many years to provide analgesia for a variety of
painful procedures in children (Kennedy & Luhmann, 2001; O\'Sullivan &
Benger, 2003; Kennedy, Luhmann, & Luhmann, 2004; Frampton et al., 2003;
Everitt, Younge, & Barnett, 2002; Krauss, 2001; Otley & Nguyen, 2000;
Luhmann et al., 1999; Burton, Auble, & Fuchs, 1998; Gregory & Sullivan,
1996; Hennrikus, Shin, & Klingelberger, 1995; Hennrikus et al.,1994;
Wattenmaker, Kasser, & McGravey, 1990; Gamis, Knapp, & Glenski, 1989;
Kalach et al., 2002; Michaud et al., 1999; Baskett, 1972; Veerkamp et
al., 1991; Veerkamp et al., 1992; Veerkamp et al., \"Dental treatment.
Part 3,\" 1993; Veerkamp et al., \"Dental treatment. Part 4,\" 1993;
Houpt, Limb, & Livingston, 2004; Shapira et al., 1992; Primosch, Buzzi,
& Jerrell, 1999; McCann et al., 1996; Wilson et al., 1998). The use of
nitrous oxide for minimal sedation is defined as the administration of
nitrous oxide (50% or less) with the balance as oxygen, without any
other sedative, narcotic, or other depressant drug before or concurrent
with the nitrous oxide to an otherwise healthy patient in ASA class I or
II. The patient is able to maintain verbal communication throughout the
procedure. It should be noted that although local anesthetics have
sedative properties, for purposes of this guideline, they are not
considered sedatives in this circumstance. If nitrous oxide in oxygen is
combined with other sedating medications, such as chloral hydrate,
midazolam, or an opioid, or if nitrous oxide is used in concentrations
more than 50%, the likelihood for moderate or deep sedation increases
(Litman et al., 1997; Litman et al., \"Chloral hydrate,\" 1998). In this
situation, the clinician must be prepared to institute the guidelines
for moderate or deep sedation as indicated by the patient\'s response
(American Academy of Pediatric Dentistry Council on Clinical Affairs,
\"Guideline on appropriate use of nitrous,\" 2005).

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=10391)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically
stated.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate monitoring and management of pediatric patients during and
after sedation for diagnostic and therapeutic procedures

#### POTENTIAL HARMS

Sedation of pediatric patients has serious associated risks, such as
hypoventilation, apnea, airway obstruction, laryngospasm, and
cardiopulmonary impairment. These adverse responses during and after
sedation for a diagnostic or therapeutic procedure may be minimized, but
not completely eliminated, by a careful preprocedure review of the
patient\'s underlying medical conditions and consideration of how the
sedation process might affect or be affected by these conditions.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The guidance in this report does not indicate an exclusive course of
    treatment or serve as a standard of medical care. Variations, taking
    into account individual circumstances, may be appropriate.

-   This revised statement reflects the current understanding of
    appropriate monitoring needs both during and after sedation for a
    procedure. The monitoring and care outlined in these guidelines may
    be exceeded at any time on the basis of the judgment of the
    responsible practitioner. Although intended to encourage
    high-quality patient care, adherence to these guidelines cannot
    guarantee a specific patient outcome. However, structured sedation
    protocols designed to incorporate the principles in this document
    have been widely implemented and shown to reduce morbidity. These
    guidelines are proffered with the awareness that, regardless of the
    intended level of sedation or route of administration, the sedation
    of a pediatric patient represents a continuum and may result in
    respiratory depression and loss of the patient\'s protective
    reflexes.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American Academy of Pediatrics, American Academy of Pediatric Dentistry,
Cote CJ, Wilson S, Work Group on Sedation. Guidelines for monitoring and
management of pediatric patients during and after sedation for
diagnostic and therapeutic procedures: an update. Pediatrics 2006
Dec;118(6):2587-602. \[213 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17142550)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1992 Jun (revised 2006 Dec)

#### GUIDELINE DEVELOPER(S)

American Academy of Pediatric Dentistry - Professional Association\
American Academy of Pediatrics - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Pediatrics

#### GUIDELINE COMMITTEE

Work Group on Sedation

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group on Sedation*: Paul Casamassimo, DDS, MS; Charles J. Coté,
MD; Patricia Crumrine, MD; Richard L. Gorman, MD; Mary Hegenbarth, MD;
Stephen Wilson, DMD, MA, PhD

*Staff*: Raymond J. Koteras, MHA

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Academy of
Pediatrics (AAP). Guidelines for monitoring and management of pediatric
patients during and after sedation for diagnostic and therapeutic
procedures. Pediatrics 1992 Jun;89(6 Pt 1):1110-5.

Guidelines for monitoring and management of pediatric patients during
and after sedation for diagnostic and therapeutic procedures: addendum.
Pediatrics 2002 Oct;110(4):836-8.

All clinical reports and policy statements from the American Academy of
Pediatrics automatically expire 5 years after publication unless
reaffirmed, revised, or retired at or before that time.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Academy of Pediatrics
(AAP) Policy Web
site](http://aappolicy.aappublications.org/cgi/content/full/pediatrics;118/6/2587).

Print copies: Available from American Academy of Pediatrics, 141
Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on April 19, 1999. It was sent to the
guideline developer for review on April 20, 1999. This summary was
updated by ECRI on October 22, 2002 to incorporate information published
in an addendum to the original guideline. The summary was verified by
the developer on November 12, 2001. This summary was updated by ECRI on
March 30, 2007. The updated information was verified by the guideline
developer on April 9, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please contact the
Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest
Point Blvd, Elk Grove Village, IL 60007.

### DISCLAIMER

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Date Modified: 11/3/2008