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ARTICLE IN PRESS
PEDIATRICS/CONCEPTS
Consensus-Based Recommendations for Standardizing
Terminology and Reporting Adverse Events for Emergency
Department Procedural Sedation and Analgesia in Children
Maala Bhatt, MD From the Division of Emergency Medicine, Montreal Children’s Hospital, McGill University,
Robert M. Kennedy, MD Montreal, Quebec, Canada (Bhatt); the Division of Emergency Medicine (Kennedy) and Division of
Pediatric Anesthesiology (McAllister), St. Louis Children’s Hospital, Washington University School
Martin H. Osmond, MDCM
of Medicine, St. Louis, MO; the Division of Emergency Medicine, Children’s Hospital of Eastern
Baruch Krauss, MD, EdM Ontario, University of Ottawa, Ottawa, Ontario, Canada (Osmond); the Division of Emergency
John D. McAllister, MD Medicine, Children’s Hospital Boston, Harvard Medical School, Boston, MA (Krauss); the
J. Mark Ansermino, MBBCh, Department of Pediatric Anesthesia, British Columbia Children’s Hospital, University of British
MSc Columbia, Vancouver, British Columbia, Canada (Ansermino); the Division of Emergency Medicine,
Stollery Children’s Hospital, University of Alberta, Edmonton, Alberta, Canada (Evered); and the
Lisa M. Evered, MD, MSc Division of Emergency Medicine, University of Minnesota Children’s Hospital Fairview, University of
Mark G. Roback, MD Minnesota Medical School, Minneapolis, MN (Roback).
Consensus Panel on Sedation
Research of Pediatric
Emergency Research
Canada (PERC) and the
Pediatric Emergency Care
Applied Research Network
(PECARN)
Children commonly require sedation and analgesia for procedures in the emergency department. Establishing
accurate adverse event and complications rates from the available literature has been difficult because of the
difficulty in aggregating results from previous studies that have used varied terminology to describe the same
adverse events and outcomes. Further, serious adverse events occur infrequently, necessitating the study of large
numbers of children to assess safety. These limitations prevent the establishment of a sufficiently large database
on which evidence-based practice guidelines may be based. We assembled a panel of pediatric sedation
researchers and experts to develop consensus-based recommendations for standardizing procedural sedation and
analgesia terminology and reporting of adverse events. Our goal was to create a uniform reporting mechanism for
future studies to facilitate the aggregation and comparison of results. [Ann Emerg Med. 2008;xx:xxx.]
0196-0644/$-see front matter
Copyright © 2008 by the American College of Emergency Physicians.
doi:10.1016/j.annemergmed.2008.09.030
SEE EDITORIAL, P. . Using the same definitions to describe sedation practices,
interventions, adverse events and time intervals is an important
first step to facilitate comparisons between studies and the
INTRODUCTION AND IMPORTANCE aggregation of data from multiple studies.12-15 Well-defined
A large number of children receive procedural sedation adverse events reported in studies of sufficiently large patient
and analgesia for diagnostic and therapeutic procedures in populations will permit improved assessment of procedural
emergency departments (EDs) each year. Although it is sedation risk and patient outcomes.
critical to establish evidence-based practice in procedural
sedation, efforts have been limited by an inability to Goals and Objectives
aggregate results from existing studies. Practice is varied and Following the International Liaison Committee on
results are reported inconsistently because investigators do Resuscitation Task Force on Cardiac Arrest and
not have a standardized set of definitions and reporting Cardiopulmonary Resuscitation Outcomes that developed
guidelines to follow.1-11 uniform definitions and reporting templates in the “Utstein
Volume xx, . x : Month  Annals of Emergency Medicine 1
ARTICLE IN PRESS
Adverse Event Reporting for Pediatric Sedation in Emergency Departments Bhatt et al
style” to standardize research reporting of cardiac arrest,16 we collection pertinent to a given term were made and direction for
created standardized definitions for sedation-related terms, future study required to develop definitive definitions was
adverse events, and time intervals. We also propose consensus- provided.
based recommendations for uniform adverse event reporting Determining the optimal measure to define adverse events
based on review of the existing pediatric sedation literature. was the greatest challenge of this project, resulting in one of the
It is our intention that the definitions and reporting most difficult decision points for the panel. The pros and cons
framework presented here be adopted by sedation researchers of including a discrete threshold and duration of an event (eg,
and used in future procedural sedation investigations. an oximeter reading of less than 90% for 30 seconds or longer
for oxygen desaturation) or interventions performed in response
MATERIALS AND METHODS to the event in the definitions were discussed at length.
In July 2007, we assembled a panel of experts in procedural Although using the traditional structure of a prespecified
sedation and analgesia from 2 national collaborative pediatric threshold and duration to describe adverse events is the most
emergency medicine research networks to establish consensus on obvious and, ostensibly, objective approach, the panel believed
uniform terms, definitions, and reporting for pediatric ED that this method may yield inaccurate and unreliable results.
procedural sedation and analgesia. The panel chairs (M.B. and Using a single numeric value to identify patients who have
M.G.R.) approached the leadership of Pediatric Emergency experienced an adverse event has several important limitations: a
Research Canada (PERC) and the Pediatric Emergency Care single threshold may miss clinically significant events (eg, a child
Applied Research Network (PECARN) for recommendations with a precipitous oxygen desaturation requiring airway
within their membership for researchers who had a particular maneuvers, who does not meet the absolute number threshold
expertise in emergency medicine, procedural sedation and
required to be considered an adverse event), is prone to
analgesia, or patient safety. The panel chairs selected a
mechanical artifact, leading to detection of clinically
representative group, composed of 6 pediatric emergency
insignificant events (eg, oximeter reads 88% but resolves
physicians and 2 pediatric anesthesiologists. PERC and
spontaneously before the clinician intervenes), and is not
PECARN were equally represented. These 2 national
uniformly applicable (eg, may not be meaningful at higher
collaborative research networks represent institutions that care
altitudes). Further, and perhaps most significantly, the duration
for approximately 1.3 million children annually in 34 EDs.
of an event is particularly difficult to assess in a clinical setting
A reference list was generated from a MEDLINE search
where precise measurement of time intervals is inaccurate and
(1950 to week 1 July 2007), using the search strategy (sedation
somewhat arbitrary when left to the clinician’s best estimation.
OR anesthesia OR analgesia) AND (emergency department OR
Intervention-based definitions were chosen because the panel
pediatrics) AND (adverse event OR adverse outcome). We
identified all articles from emergency medicine or anesthesia believes this framework will yield the greatest possibility of
that contained information on sedation-related adverse uniform data collection for clinically important events.
outcomes, searched the bibliographies of all identified articles, Definitions using this approach require specific clinical criteria
and queried the expert panel for additional relevant articles. A to be present and for one or more interventions to be performed
draft list of sedation terms, adverse events, and definitions of with the intention of treating or managing the event. The
these items found in the reference list articles was compiled and presence or absence of an intervention performed in response to
circulated to panel members. Consensus was reached on which a clinical event is a reproducible measure and reflects the
events should be routinely reported in future pediatric ED clinician’s interpretation of the significance of the event in the
sedation studies. clinical context. The panel does recognize that interventions
We used electronic communication, teleconferencing, and performed reflect the provider’s clinical judgment and experience
one face-to-face meeting to review the literature, discuss and may not necessarily be absolutely required. However, by
terminology, and reach consensus on definitions and including the number and type of interventions performed, as
recommendations for uniform reporting of adverse events. All well as the documentation of objective characteristics (eg, lowest
members participated in discussions on each topic, and reliable oxygen saturation observed), researchers will be able to
consensus was reached through debate and dialogue that was determine the severity and significance of each event.
not time limited. Some terms and concepts, including The panel considered several hypothetical scenarios of
laryngospasm, depth of sedation, and determining the optimal adverse events, and all would have had 1 or more intervention(s)
format for the definitions of adverse events, were more difficult performed. An intervention could have been as simple as airway
to ratify. Disagreement between panel members was resolved repositioning. We contend that researchers are not concerned
through repeated discussion (teleconference and face-to-face with events that are extremely short lived (seconds) or resolve
meeting) until unanimous group consensus was reached. During spontaneously (error in equipment reading or are an expected
a meeting at Mont Tremblant, Quebec, on January 28, 2008, physiologic effect) and thus are of questionable clinical
the panel rediscussed all terms and ratified their definitions. significance. Documenting interventions performed yields
When the existing literature was deemed insufficient to come to reproducible measures that will lead to more standardized and
a consensus agreement on definition, recommendations for data accurate data collection. Although this approach is not
2 Annals of Emergency Medicine Volume xx, . x : Month 
ARTICLE IN PRESS
Bhatt et al Adverse Event Reporting for Pediatric Sedation in Emergency Departments
instinctive, it is our belief that it will allow sedation researchers Presedation State
to collect a robust data set of clinically important adverse events Definition. The patient’s behavioral state immediately
with a range of severity defined by the number and type of before sedation. A child’s behavior can be characterized as calm
interventions performed while minimizing the recording of (eg, not crying), agitated but responds to comforting (eg, briefly
events whose significance is difficult to interpret. stops crying), or agitated and does not respond to comforting
Our intent was to create a comprehensive core data set of (eg, continuous crying).
adverse events to be reported. Researchers may choose to study a Rationale. A child’s behavioral state before sedation may affect
subset of terms applicable to their chosen study hypothesis. the dose of sedative required, unpleasant recall of the procedure, or
Similarly, for their specific research needs they may add to this unpleasant recovery reactions.5,21,22 Presedation agitation has been
data set as they desire. described by several authors, but no definitions or validated
The content of this article has been endorsed by the research measures exist. Two studies have collected data on this entity: one
networks of PERC and PECARN. using a visual analog scale22 to rate the degree of agitation and the
other using an ordinal scale.23 Because of limitations in using a
single visual analog scale measurement to compare groups of
SEDATION TERMINOLOGY individuals,24 and in the absence of a validated measure, we suggest
Procedural Sedation and Analgesia using a simple ordinal scale to describe the patient’s behavior. We
Definition. Procedural sedation and analgesia, commonly recommend that investigators describe in the methods section how
referred to as “sedation,” is the use of anxiolytic, sedative, a child’s behavioral state was assessed and any interventions that
analgesic, or dissociative drugs to attenuate pain, anxiety, and were performed to affect this state.
motion to facilitate the performance of a necessary diagnostic or
therapeutic procedure, provide an appropriate degree of amnesia
or decreased awareness, and ensure patient safety.17,18 Depth of Sedation
Definition. Depth of sedation has been qualitatively defined
Commentary. “Conscious sedation” is a misleading and
and described as a continuum, progressing from mild through
outdated term that should no longer be used in research or
moderate to deep sedation and potentially to general anesthesia.25-
clinical practice.19 The use of analgesic drugs alone is not
29 Identifying depth of sedation is important because it is believed
considered sedation.
that the risk of adverse events increases as patients become more
deeply sedated. The correlation between depth of sedation and risk
Presedation Assessment of adverse events is altered with ketamine because of its unique
Definition. A focused history and physical examination to dissociative properties.20,30-32
determine factors that may influence the selection of the Rationale. Depth of sedation should be part of the patient
sedation technique and affect the safety of the sedation.20 This assessment and reported in research to help understand the efficacy
evaluation includes ascertainment of current or past patient and safety of the sedation technique. Scales commonly used to
health issues, the indications for sedation, previous patient assess depth of sedation were developed to determine a patient’s
experience with sedation or anesthesia, and the presence of state of recovery or have not been validated in the ED setting.33-36
airway or other conditions that may affect the efficacy of the Because of these limitations, we are unable to endorse a specific tool
sedation or the incidence of side effects, adverse events, or or definition for this term. Further research is needed to objectively
complications. define the stages on the continuum and to create or validate a tool
Rationale. Patients exhibit variable responses to sedative and for use in the ED setting. It is important for investigators to state in
analgesic drugs. The presedation assessment guides the selection the methods section how depth of sedation is quantified.
of the sedation technique. Drug dose requirements, depth of
sedation, and frequency of adverse events may be influenced by Efficacy of Sedation
a variety of patient factors such as age, coexisting illness or Definition. The creation of conditions necessary to safely
injury, pharmacogenetic factors, and psychological or anatomic facilitate the completion of a procedure through attenuation of
variability. Documentation of relevant factors gleaned during pain, anxiety and movement with amnesia or decreased
the presedation assessment and correlation with adverse events awareness.11,17,18 All of the following criteria must be present for a
may lead to improved recognition of specific risk factors for sedation to be considered efficacious:37
sedation-related adverse events. Future procedural sedation and a) The patient does not have unpleasant recall of the
analgesia research will progress by identifying risk factors for procedure.
adverse events and by evaluating strategies to minimize b) The patient did not experience sedation-related adverse
sedation-related adverse events. We recommend that future events resulting in
research include a statement that this assessment was performed abandonment of the procedure or
and that relevant patient or situational risk factors and a permanent complication (Section VIII) or
potentially confounding variables were assessed in the context of an unplanned admission to the hospital or prolonged ED
the specific research question. observation
Volume xx, . x : Month  Annals of Emergency Medicine 3
ARTICLE IN PRESS
Adverse Event Reporting for Pediatric Sedation in Emergency Departments Bhatt et al
c) The patient did not actively resist or require physical their occurrence are of vital importance in the identification of
restraint for completion of the procedure. The need for the risk factors for and causes of adverse events associated with
minimal redirection of movements should not be procedural sedation. The panel has recommended reporting all
considered as active resistance or physical restraint. sedation events that result in an intervention or a change in
Commentary. Presence of any of the above criteria is disposition from the ED. All clinically relevant events, from
considered a sedation failure. minor (eg, mild desaturation requiring a jaw thrust) to more
Rationale. Previous researchers have described sedation serious (eg, clinically apparent pulmonary aspiration), will be
failure as the inability to complete a procedure because of captured with this method. Only transient or minor physiologic
patient anxiety, pain, or distress.9 We have expanded this effects that have no clinical consequence (eg, minor changes in
definition to include the patient’s perception of efficacy (lack of the pulse rate, respiratory rate, and blood pressure caused by
unpleasant recall of the procedure) and have added a measure of many sedation drugs) will not be detected with this framework.
safety in delivering the sedation. We are unable to endorse a These events do not require a change in the sedation plan and
specific measure of patient distress because there are no were deemed not to contribute to the understanding of the risk
validated tools that are easily applicable in this setting. Further factors for and causes of adverse events associated with
research is needed to objectively define and quantify this term in procedural sedation.
the ED setting. It is important for investigators to state in the The adverse events listed below fall into several categories:
methods section how efficacy of sedation is quantified. respiratory (oxygenation or ventilation-associated and clinically
apparent pulmonary aspiration), vomiting, cardiovascular
Readiness for Discharge (bradycardia and hypotension), excitatory movements
Definition. The time at which a patient emerges from the (myoclonus, muscle rigidity, and generalized seizure), adverse
effects of sedation to a level of consciousness that reflects behavioral reactions (paradoxic response to sedation and
satisfactory physiologic recovery (ability to achieve a satisfactory unpleasant recovery reaction), and permanent complications
state of wakefulness and maintain a patent airway without (neurologic injury and death).
respiratory depression and return to baseline motor function Patients may experience more than one category of adverse
and vital signs) and demonstrates adequate pain control. events, as well as more than one type of adverse event within a
Rationale. Readiness for discharge is an important outcome given category. All events should be reported separately, even
measure in sedation research because it defines clinical recovery when occurring in the same category (eg, apnea associated with
from the pharmacologic effects of sedation. Reporting time to oxygen desaturation should be reported as 2 separate events).
physiologic recovery will allow researchers to identify trends and We provide definitions for adverse events (below), sedation
quantify recovery times for sedation agents. We recommend intervals (Figure), and a template for adverse event data
that investigators document the time to physiologic recovery in collection for sedation research (Appendix E1, available online
addition to the time of actual ED discharge because many at http://www.annemergmed.com).
factors unrelated to a patient’s recovery from sedation such as
the availability of diagnostic imaging, consultants, ED staff, and OXYGENATION
ED patient census influence the time a patient is actually
1.1 Oxygen Desaturation
discharged from the ED. Many consensus-based criteria exist to
Definition. Oxygen desaturation and one or more
confirm a patient’s readiness for discharge; however, none have
interventions are performed with the intention of improving the
been objectively studied or validated. Further research is needed
oxygen saturation.3,38-40 The interventions include the
to objectively define and quantify this term in the ED setting.
following:
We recommend that investigators document in the methods
a) Vigorous tactile stimulation
section criteria used to define readiness for discharge.
b) Airway repositioning— chin lift, jaw thrust, neck extension,
midline repositioning
SEDATION INTERVALS
c) Suctioning
The time of sedation may be broken into 4 distinct intervals
d) Supplemental or increased oxygen delivery
or phases: presedation, sedation, ED recovery, and
e) Oral or nasal airway placement
postdischarge. Definitions, as well as subphases, are listed and
f) Application of positive pressure or ventilation with bag mask
defined in the Figure. It has been postulated that patients’ risk
g) Tracheal intubation
for certain adverse events varies with their phase of sedation.
Further study of adverse events and severity by sedation interval Rationale. Definitions for oxygen desaturation use a
is warranted. We recommend that investigators record the times combination of threshold and duration of desaturation to
a patient begins and ends all phases and subphases. describe the event (eg, oxygen saturation 90% for 30
seconds).41-43 We chose an intervention-driven definition
ADVERSE EVENT TERMINOLOGY because a prespecified threshold may miss some cases of
Accurate reporting of adverse events, the circumstances important desaturation. For example, a child who has been
surrounding these events, and the interventions that result from preoxygenated to 100% may experience a precipitous decrease
4 Annals of Emergency Medicine Volume xx, . x : Month 
ARTICLE IN PRESS
Bhatt et al Adverse Event Reporting for Pediatric Sedation in Emergency Departments
Administration of medications for
anxiolysis or analgesia that are given
Pre-sedation Pre-sedation
without the intention of sedation are
given during this period
Pre-sedation Sedation ED Recovery Post
Discharge
Immediate Induction Maintenance Physiologic
Pre-sedation Recovery
Start of pre- Start of End of End induction End of End of End of ED End of post
sedation phase immediate pre- immediate pre- phase maintenance and physiologic recovery phase discharge
sedation phase sedation & pre- AND sedation phases recovery phase AND phase
Time of initial sedation phase Start of AND Start of post-
sedation specific Time AND maintenance Start of Time the patient discharge phase 24 hours after
patient immediately Start of phase physiologic and returns to a the beginning
assessment prior to the induction phase ED recovery physiologic state Time of of the sedation
administration Time procedure allowing safe discharge from phase
of sedation phases
of medications, is started discharge from the ED or
during which the Time of the start the ED time of
final patient of Time procedure
admission to
assessment is administration is completed.
hospital
completed. of medications No further
This includes with the intent sedatives are
NB: this may be
vital sign of sedation given after this
the same time as
measurement& point.
time of
evaluation of physiologic
pre-sedation recovery
agitation
Figure. Sedation time intervals.
in saturation to 90% that is managed by the administration of 2.2 Apnea: Obstructive
supplemental oxygen and maneuvers to reposition the airway. 2.2.1 Partial Upper Airway Obstruction
This event is clinically relevant yet would be missed if a Definition. Incomplete obstruction to air exchange
threshold alone were used to define oxygen desaturation. manifested by the presence of one or more of the following:
Further, duration of desaturation is difficult to accurately assess. a) Stridor
All clinically significant cases will be captured in the proposed b) Snoring
intervention-driven definition. Researchers will be able to c) Chest wall and suprasternal retractions AND rapid
distinguish the severity of desaturation with the documentation resolution with one or more of the following interventions
of lowest oxygen saturation, use of preoxygenation, and the to treat the partial airway obstruction:9,49,50
number and type of interventions performed. a) Airway repositioning
b) Suctioning
VENTILATION c) Oral or nasal airway placement
2.1 Apnea: Central d) Application of positive pressure with bag mask but without
Definition. Cessation or pause of ventilatory effort and one assisted ventilation
or more interventions are performed with the intention of
stimulating or assisting ventilation. The interventions include Rationale. Most existing studies include partial airway
the following: obstruction in a general category of respiratory adverse
a) Vigorous tactile stimulation events.5,7,41 We believe it is important to distinguish partial
b) Application of bag mask with assisted ventilation from complete airway obstruction because the interventions,
c) Tracheal intubation treatments, and outcomes may be quite different. We chose a
d) Administration of reversal agents (opioid or benzodiazepine definition according to specific criteria and the requirement for
antagonists) either an airway maneuver or the application of positive pressure
with a bag mask apparatus continuous positive airway pressure
Rationale. Definitions for apnea describe the event as a in an attempt to alleviate the obstruction.9,49 Airway
loss of respiratory effort for a specified duration (eg, no obstruction that does not rapidly and easily respond to these
respiratory effort for 30 seconds).2,44-48 We chose an simple interventions does not meet the requirements for partial
intervention-driven definition because accurate measurement of airway obstruction and must be reclassified.
apnea duration is difficult. Researchers will be able to verify
whether patients met the definition of central apnea by 2.2.2 Complete Upper Airway Obstruction
documenting the criteria used for recognition of the event and Definition. Ventilatory effort with no air exchange* and
will be able to assess severity by the number and type of one or more of the following interventions are performed with
interventions performed. the intention of relieving complete airway obstruction:
Volume xx, . x : Month  Annals of Emergency Medicine 5
ARTICLE IN PRESS
Adverse Event Reporting for Pediatric Sedation in Emergency Departments Bhatt et al
a) Airway repositioning physiologic recovery phase and the appearance of respiratory
b) Suctioning signs and symptoms that were not present before the
c) Oral or nasal airway placement sedation.56,57 The new signs and symptoms must present before
d) Application of positive pressure with bag mask / assisted the end of the ED recovery phase (Figure).
ventilation (i) Physical signs
e) Tracheal intubation Cough
f) Administration of additional sedation agents Crackles/rales
g) Administration of neuromuscular blockade agents Decreased breath sounds
*No air exchange is manifested by the absence of upper airway Tachypnea
(eg, stridor or snoring) and breath sounds on auscultation and Wheeze
the loss of CO2waveform, when capnography is used. Rhonchi
Respiratory distress
2.3 Laryngospasm (ii) Oxygen requirement
Definition. Partial or complete upper airway obstruction, Decrease in oxygen saturation from baseline, requiring
with oxygen desaturation cau


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