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The Revised Face Legs Activity Cry and Consolability (FLACC) Observational Pain Tool

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The revised FLACC observational pain tool:
improved reliability and validity for pain
assessment in children with cognitive impairment
SHOBHA MALVIYA MDMD, TERRI VOEPEL-LEWIS MSN RNMSN RN,
CONSTANCE BURKE BSN RNBSN RN,SANDRAMERKELMS RNMS RN AND
ALAN R. TAIT PPhhDD
Department of Anesthesiology, University of Michigan Health Systems, Ann Arbor, MI, USA
Summary
Background: Difficulty with pain assessment in individuals who
cannot self-report their pain poses a significant barrier to effective pain
management. However, available assessment tools lack consistent
reliability as pain measures in children with cognitive impairment
(CI). This study evaluated the validity and reliability of the revised
and individualized Face Legs Activity Cry and Consolability (FLACC)
behavioral pain assessment tool in children with CI.
Methods: Children with CI scheduled for elective surgery were
studied. The FLACC was revised to include specific descriptors and
parent-identified, unique behaviors for individual children. The
child’s ability to self-report pain was evaluated. Postoperatively, two
nurses scored pain using the revised FLACC scale before and after
analgesic administration, and, children self-reported a pain score, if
able. Observations were videotaped and later viewed by experienced
nurses blinded to analgesic administration.
Results: Eighty observations were recorded in 52 children aged
4–19 years. Twenty-one parents added individualized pain behaviors
to the revised FLACC. Interrater reliability was supported by excellent
intraclass correlation coefficients (ICC, ranging from 0.76 to 0.90) and
adequate j statistics (0.44–0.57). Criterion validity was supported by
the correlations between FLACC, parent, and child scores (q ¼ 0.65–
0.87; P < 0.001). Construct validity was demonstrated by the decrease
in FLACC scores following analgesic administration (6.1 ± 2.6 vs
1.9 ± 2.7; P < 0.001).
Conclusions: Findings support the reliability and validity of the
FLACC as a measure of pain in children with CI.
Keywords: pain assessment; developmentally delayed children; face
legs activity cry and consolability pain tool
Correspondence to: Shobha Malviya MD, Department of Anesthesiology, Section of Pediatrics, University of Michigan Health Systems, F3900
Box 0211, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-0211, USA (email: smalviya@umich.edu).
Pediatric Anesthesia 2006 16: 258–265 doi:10.1111/j.1460-9592.2005.01773.x
258 � 2005 Blackwell Publishing Ltd

Introduction
Routine pain assessment has been shown to improve
pain management for adults and children (1) and is
considered essential for optimal care (2, 3). How-
ever, difficulty with pain assessment in individuals
who cannot self-report their pain poses a significant
barrier to effective pain management (4). While
some individuals with cognitive impairment (CI) are
able to identify the presence of pain, others cannot
do so and most particularly the moderately to
severely impaired, are unable to quantify its severity
(5–11). The availability of valid and reliable obser-
vational methods to assess pain in this population is
therefore imperative to facilitate effective manage-
ment.
Recent studies have described a set of core pain
behaviors in the cognitively impaired (12–15),
many of which are similar to those evident in
cognitively intact children. Behavioral categories
that have been incorporated into existing pediatric
scales may, therefore, provide a reasonable frame-
work to facilitate the objective measure of pain in
these children. Indeed, five such tools have been
tested in small samples of children with CI, and
have been shown to have variable validity and
reliability (5, 16–18). Breau et al. (16) tested the
reliability and validity of the Noncommunicating
Children’s Pain Checklist – Postoperative Version
(NCCPC-PV) in 25 children with severe CI. This
tool requires the scoring of each of 27 types of
behavior in six subscales from 0 ¼ not observed at
all, to 3 ¼ observed very often. Although ambigu-
ous from their report, it appears that the composite
score could range from 0 to 81. Breau et al. (16)
reported fair interrater reliability for each of the
subscales with the poorest reliability in the categ-
ories of Sociability, and Body and Limbs. The small
sample size and its restriction to the severely
impaired, however, limit the ability to generalize
these findings to other populations of children with
CI. Additionally, the length and nature of this
checklist diminishes its utility for routine pain
assessment in clinical settings. The Wisconsin
Children’s Hospital Pain Scale (UWCH) was found
to have reasonable reliability and validity in 59 pre-
verbal and 15 nonverbal (i.e. CI) children (18).
However, the categories and scoring style of this
tool may limit its precision, and are incongruent
with most other commonly used measures of pain.
Lastly, Schade et al. (17) reported acceptable inter-
rater reliability and discriminant validity as well as
a high degree of clinical utility for the Nursing
Assessment of Pain Intensity (NAPI) in a small
sample of children with cerebral palsy.
The Face Legs Activity Cry and Consolability
(FLACC) has been found to have reasonable inter-
rater reliability and validity as a measure of pain in
children with varying degrees of CI (5). This simple
tool contains five categories, each of which are
scored from 0 to 2 to provide a total score ranging
from 0 to 10. However, while measures of agreement
between observers were found to be acceptable for
comparisons in the Face, Cry and Consolability
categories, there was low agreement in the Legs and
Activity categories, similar to findings of Breau et al.
(16) Lower agreement in these subcategories of
existing pain tools may be explained, in part, by
the presence of underlying motor impairments,
including spasticity, which may cloud behavioral
observations. Additionally, some cognitively im-
paired adults and children have been shown to
exhibit unusual pain behaviors including atypical
facial responses, laughing, clapping of hands, fid-
geting, anger, aggressiveness and self-injury (13,19–
23), that have not been addressed in existing pain
tools. Incorporating such behaviors may improve the
validity and reliability of existing pain measures,
which may in turn improve our ability to adequately
treat pain in this population.
The objectives of the present study were: (i) to
revise the FLACC pain assessment tool to include
behaviors specific to those with CI, and; (ii) to
evaluate the validity and reliability of the revised
FLACC in children with CI. The hypothesis tested
was that the revised FLACC tool is a valid and
reliable measure of pain in this population.
Methods
This study was approved by the Institutional Review
Board at the University of Michigan. Prior to
recruitment, the FLACC instrument was revised
using the following methods. A thorough review of
the literature yielded a comprehensive list of pain
behaviors common to individuals with CI including;
agitation, verbal outbursts, tremors, shivering,
hypertonicity or increased spasticity, breath holding,
PAIN ASSESSMENT IN COGNITIVELY IMPAIRED CHILDREN 259
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and gasping (13–15,21,24,25). With reference to this
list of behaviors, videotaped segments from a pre-
vious study (5) were reviewed to identify those most
commonly observed in children with CI who exhib-
ited pain following surgery. The categories them-
selves (i.e. Face, Legs, Activity, Cry, and
Consolability) were unchanged in the revised
FLACC tool; however, descriptors were added to
incorporate those that were most consistently asso-
ciated with pain in individuals with CI. FLACC
revisions focused primarily on the expansion of
descriptors in the least reliable categories (i.e. Legs
and Activity). Additionally, as individuals with CI
may exhibit idiosyncratic baseline as well as pain
behaviors (20, 21, 23, 24), an open-ended descriptor
under each category was added to permit parents/
caregivers to record divergent pain behaviors for
such patients. In order to confirm its content valid-
ity, the revised instrument (Table 1) was finally
reviewed by several physicians and advanced
Table 1
Revised face legs activity cry and consolability tool and a sample description of individual behavior provided by parents (revisions noted
in italics)
Individual behavior
a
Face
0 ¼ No particular expression or smile
1 ¼ Occasional grimace/frown; withdrawn
or disinterested; appears sad or worried
2 ¼ Consistent grimace or frown; frequent/
constant quivering chin, clenched jaw; distressed-looking face;
expression of fright or panic
Individualized behavior:___________
‘Pouty’ lip; clenched and grinding teeth;
eyebrows furrowed; stressed looking; stern face;
eyes wide open – looks surprised;
blank expression; nonexpressive
Legs
0 ¼ Normal position or relaxed; usual tone & motion to limbs
1 ¼ Uneasy, restless, tense; occasional tremors
2 ¼ Kicking, or legs drawn up; marked increase in spasticity,
constant tremors or jerking
Individualized behavior:________
Legs and arms drawn to center of body;
clonus in left leg with pain;
very tense and still; legs tremble.
Activity
0 ¼ Lying quietly, normal position, moves easily;
Regular, rhythmic respirations
1 ¼ Squirming, shifting back and forth, tense or guarded movements;
mildly agitated (e.g. head back and forth, aggression); shallow,
splinting respirations, intermittent sighs.
2 ¼ Arched, rigid or jerking; severe agitation;
head banging; shivering (not rigors);
breath holding, gasping or sharp intake of breaths, severe splinting
Individualized behavior:__________
Grabs at site of pain; nods head; clenches fists,
draws up arms; arches neck; arms startle;
turns side to side; head shaking; points to where it hurts;
clenches fist to face, hits self, slapping; tense, guarded,
posturing; thrashes arms; bites palm of hand; holds breath.
Cry
0 ¼ No cry/verbalization
1 ¼ Moans or whimpers; occasional complaint;
occasional verbal outburst or grunt
2 ¼ Crying steadily, screams or sobs, frequent complaints;
repeated outbursts, constant grunting
Individualized behavior:_________
States, ‘I’m okay’ or ‘All done’; mouth wide open & screaming;
states ‘Owie’ or ‘No’; gasping, screaming;
grunts or short responses; whining, whimpering,
wailing, shouting; asks for medicine; crying is rare.
Consolability
0 ¼ Content and relaxed
1 ¼ Reassured by occasional touching,
hugging or being talked to. Distractible.
2 ¼ Difficult to console or comfort; pushing away caregiver,
resisting care or comfort measures
Individualized behavior:___________
Responds to cuddling, holding, parent,
stroking, kissing; distant and unresponsive when in pain.
a
Excerpts from the additional descriptions of the individual child’s pain behavior recorded by parents on the revised Face Legs Activity Cry
and Consolability (FLACC) tool during the preoperative interview. Only 21 parents added such comments to the revised FLACC.
260 MALVIYA ET AL.
� 2005 Blackwell Publishing Ltd, Pediatric Anesthesia, 16, 258–265

practice nurses who are experts in pain assessment
and treatment and in assessment of children with CI
via their daily clinical duties and/or work on the
pediatric pain service.
With parental consent and child assent, when
applicable, children with CI aged 4–21 years of age
scheduled for elective surgery were included. Pre-
operatively, demographic data were recorded and
parents were interviewed regarding details of the
child’s developmental level and communication
skills. The child’s level of impairment was grossly
estimated from parent interview, and by calculating
a Deviation IQ Score (DIQ) as: [(developmental age
estimate/chronological age) · 100], which was cat-
egorized as mild, moderate or severe in accordance
with the American Psychiatric Association’s DSM-IV
guidelines for diagnosing mental retardation (26).
Additionally, children were evaluated for the pres-
ence, extent, and nature of spasticity, mobility, and
movement disorders. More specifically, children
were tested for their ability to communicate and
self-report their pain using a technique described
previously (5,6). This testing determined the child’s
ability to understand magnitude and order using a
series of blocks, numbers, and a Simplified Faces
Scale (Figure 1). Children who completed all tests
were asked how they would prefer to score their
pain during the postoperative period (i.e. using
either the verbal 0–10 Numbers Scale; the Simplified
Faces Scale; or a Simple Word Scale – ‘little, medium,
or big’). Lastly, parents were asked to review the
FLACC pain instrument, and to record additional
behavior that may better indicate acute pain in their
child (i.e. behavior they have observed during
painful episodes). These types of behavior, as well
as notations regarding baseline spasticity and mobil-
ity, were incorporated into an ‘individualized’
FLACC tool that was used for all subsequent
assessments of the child.
Following emergence from general anesthesia and
prior to the administration of analgesics, patients
were observed and scored for pain behavior using
the revised and individualized FLACC pain tool. All
observations were made when the child was awake,
and most when in the presence of a parent/guard-
ian. Observations were made either in the recovery
area or on the general care units. Two nurses trained
in the use of the modified FLACC simultaneously
but independently observed and recorded pain
scores. In addition, parents simultaneously yet
independently recorded a global rating of their
perception of the child’s pain using a 0–10 cm VAS
(0 ¼ no pain; 10 ¼ worst possible pain). For those
children deemed able to self-report, a pain score was
obtained using either the 0–10 numbers scale, the
simplified faces scale, or a simple word scale (i.e.
‘small, medium, big’ pain), based on the child’s
predetermined abilities and preference. Children
were videotaped throughout each observation. Par-
ents and/or caregivers were encouraged to interact
with and console the child, but did not discuss pain
scores or assessment during the taping. Analgesics
were given as needed at the discretion of the care
providers, and, for those children requiring treat-
ment, observations were repeated in the same
manner at 30 min following analgesic admini-
stration.
On completion of recruitment, videotaped seg-
ments were randomly mixed, and later viewed by
four nurses expert in pediatric pain assessment, who
were blinded to the administration of analgesics and
to all other assigned pain scores. These nurses
assigned pain scores independently using the modi-
fied, individualized FLACC tool for half of the
segments, and the NAPI (17) for the other half. This
tool was chosen over others because of its similarity
in structure and ease of use in the clinical setting.
Two of these independent observers viewed and
scored twenty randomly selected segments each on a
second occasion, 3–4 weeks after the first viewing to
evaluate test-retest reliability.
Spearman’s q and ICC were used to determine the
strength of association and measure of chance-
corrected agreement between scores. The bias
between parent and nurse scores was determined
by subtracting the bedside nurse and observer scores
from parent scores and are presented as mean (bias)
and SDSD (precision). Exact agreement between FLACC
scores was determined using % agreement with
kappa statistics (j), where applicable. Scores before
Figure 1
Simplified faces scale.
PAIN ASSESSMENT IN COGNITIVELY IMPAIRED CHILDREN 261
� 2005 Blackwell Publishing Ltd, Pediatric Anesthesia, 16, 258–265

and after analgesic administration were compared
using Wilcoxon signed rank tests for paired data.
Correlations ‡0.6 were considered good to excellent
associations; j values ‡0.41 were considered ade-
quate agreement; and P < 0.05 was accepted as
statistically significant.
The sample size was based on the following
clinical and statistical assumptions: 25 observations
would be needed to reveal a correlation of 0.6
(a ¼ 0.05; b ¼ 0.1), which was considered acceptable
for the FLACC subcategory reliability comparisons.
As this study sought to demonstrate reliability of the
FLACC at varying levels of pain, i.e. mild, moderate,
and severe, 25 observations were required at each
pain intensity (i.e. 75 observations in all). Based on
the sample obtained in our previous study (5), it was
estimated that approximately 60 children would
need to be recruited to ensure at least this number of
observations. This sample size was determined to be
sufficiently large to satisfy the more robust correla-
tions and comparisons required for interrater, test-
retest, criterion and construct validity.
Results
Eighty observations from 52 children were obtained
for this study (Table 2). Twelve children successfully
completed the tasks necessary to self-report their
pain intensity and chose to use either the Simplified
Faces Scale (n ¼ 4), 0–10 Numbers scale (n ¼ 3), or a
Simple Word Scale (Little Hurt, Medium Hurt, Big
Hurt; n ¼ 5). Most parents confirmed that behavi-
oral descriptors in the FLACC tool were represen-
tative of pain behavior in their child; however, 21
parents identified additional types of behavior that
were indicative of pain in their children (Table 1).
The interrater reliability of the FLACC was sup-
ported by the excellent ICCs and acceptable meas-
ures of exact agreement between observers for each
of the categories as well as for the total score
(Table 3). FLACC scores were coded as mild (scores
0–3), moderate (4–6) and severe (7–10), based on
previously defined clinically significant pain cate-
gories (27–29), to examine reliability for clinically
relevant scores; and, analyses demonstrated good to
excellent interrater agreement for these scores. To
determine whether the reliability of the revised
FLACC tool is lower in children with spasticity,
agreement was compared between those with and
without spasticity for the motor components of the
FLACC. Exact agreement was 42–84% (j ¼ 0.41)
and 55–74% (j ¼ 0.41) for the Legs and Activity
categories, respectively, in children with spasticity
(n ¼ 118); vs 43–87% (j ¼ 0.49) and 33–89%
(j ¼ 0.53) for those without spasticity (n ¼ 88).
Test-retest reliability was supported by the excellent
ICC (n ¼ 32; ICC ¼ 0.97; C.I. ¼ 0.92–0.99) for
repeated FLACC scores of the independent video
observers.
Criterion validity was supported by moderate to
high correlations between observers’ FLACC scores,
Table 2
Description of the study sample (n ¼ 52)
Age 11.3 ± 4.7
Gender (female, %) 20 (39)
Surgical procedures
Orthopedic 29 (56)
Oral surgery 8 (15)
Otologic 6 (12)
General surgery/other 9 (17)
Diagnosis
Cerebral palsy 26 (51)
Syndrome with CI 9 (18)
Autism 8 (16)
Other 8 (15)
Degree of impairment
Mild (DIQ ¼ 82 ± 5.9) 16 (31)
Moderate (DIQ ¼ 45.3 ± 12.5) 12 (23)
Severe (DIQ ¼ 11.3 ± 5.6) 24 (46)
Spasticity 31 (61)
Quadriplegia 25 (49)
Hemiplegia 4 (8)
Diplegia 2 (4)
DIQ, Deviation IQ Score.
Table 3
Interrater reliability between all nurse observers
a
ICC (confidence interval)
b
% agreement (j)
Face 0.86 (0.83–0.89) 53–81 (0.57)
Legs 0.77 (0.70–0.83) 46–86 (0.44)
Activity 0.75 (0.68–0.80) 50–78 (0.45)
Cry 0.87 (0.83–0.89) 46–89 (0.55)
Consolability 0.76 (0.70–0.81) 64–82 (0.48)
Total score 0.90 (0.87–0.92) NA
Coded pain scores
c
0.83 (0.78–0.86) 35–89 (0.50)
ICC, intraclass correlation coefficients
a
Comparisons for 282 paired observations between video observ-
ers, the bedside nurse and the bedside observer.
b
All correlations significant at P < 0.001
c
Scores were coded as mild (0–3), moderate (4–6) and severe
(7–10) for these comparisons.
262 MALVIYA ET AL.
� 2005 Blackwell Publishing Ltd, Pediatric Anesthesia, 16, 258–265

the parents’ global pain ratings, the NAPI scores,
and the available child ratings (Table 4). Parent
scores tended to be higher than nurse and observer
FLACC scores (bias ¼ 1.4; precision ¼ 2.2), as well
as video observer FLACC scores (bias ¼ 1.97; preci-
sion ¼ 2.7). FLACC scores significantly decreased
following analgesic administration for both the
bedside nurses’ assigned scores (n ¼ 20; 6.1 ± 2.5
vs 2.2 ± 2.4; P < 0.001) and the blinded video
observers’ scores (n ¼ 20; 6.1 ± 2.6 vs 1.9 ± 2.7;
P < 0.001), supporting the construct validity of the
revised tool. Additionally, parent-assigned pain
scores similarly decreased (n ¼ 12; 6.6 ± 2.4 vs
2.6 ± 2; P ¼ 0.003).
Discussion
Effective pain management for children with CI is
dependent upon the ability of care providers to
reliably observe and assess the presence and inten-
sity of pain. Yet, as recent investigators have pointed
out, no standard measure of pain exists for this
population (30). Pain tools that have been previously
tested in this population are either lengthy or
difficult to incorporate into routine care or lack
consistent reliability. This study demonstrated that
the revised and individualized FLACC tool is a
reliable and valid measure of pain in children with
CI. This tool offers clinicians an objective method of
pain assessment, which may in turn reduce the
under-treatment of pain in this vulnerable popula-
tion.
The FLACC tool was originally designed as a
simple observational tool to assess pain in young
children who could not self-report their pain (31).
The tool is structured around five categories that
have been shown to be reliable indicators of pain in
children (27). Many of the types of behavior des-
cribed in the tool have, additionally, been shown to
be reliable and sensitive pain indicators in individ-
uals with CI (12,15). These original behavioral
descriptors, although not comprehensive, were
meant to provide clinicians guidance in making
observations and scoring pain intensity. A previous
study in children with CI demonstrated that the
Legs and Activity categories of the original FLACC
were less reliable than other categories, suggesting
that some individuals with CI exhibit a different
constellation of pain behavior compared with
healthy, cognitively intact children (5). Similar find-
ings were demonstrated by Breau et al. (16) who
found that Body, Limbs and Social categories in their
pain tool were less reliable, and by Terstegen et al.
(12) who showed that facial expressions were more
sensitive indicators of pain compared with motor
behavior. The revised FLACC tool incorporates
several additional behavioral descriptors, including:
verbal outbursts, tremors, increased spasticity, jerk-
ing movements, and respiratory pattern changes
such as breath holding and grunting. This study
demonstrates an improvement in reliability meas-
ures for all categories as well as for total FLACC
scores and coded scores, when compared with our
previous study. These findings suggest that the
addition of specific behavioral descriptors under the
relevant FLACC categories improved the reliability
of pain assessment for these children.
In addition to expanded behavioral descriptors,
the revised FLACC allows for individualization of
the tool via open-ended descriptors in each category.
Previous studies have described unique pain behav-
ior in cognitively impaired elderly adults and
children, including verbal outbursts and perseverant
verbalizations (13), aggression or agitation (19, 20),
and self-injurious behavior (21,23,32). Additionally,
based on their clinical experience Solodiuk and
Curley (33) recommended the incorporation of
parent-identified descriptors into a commonly used
numeric scale to facilitate pain assessment for
impaired children. Nearly half of the children in
our study were described by their parents as having
Table 4
Correlations between the nurses’ and observers’ Face Legs
Activity Cry and Consolability (FLACC) and nursing assessment
of pain intensity (NAPI) scores, Parent Global Scores, and child
ratings
Parent
(n ¼ 66)
Child
a
(n ¼ 12)
Video observer
NAPI (n ¼ 77)
Nurse FLACC (n ¼ 80) 0.74
b
0.78
b
0.78
b
Bedside observer
FLACC (n ¼ 80)
0.82
b
0.86
b
0.87
b
Video observer
FLACC (n ¼ 77)
0.65
b
0.67
c
0.78
b
Samples variable based on parent availability, child ability to
score pain, and quality of the video segments.
a
Scores were coded as mild (0–3), moderate (4–6) and severe
(7–10) for these comparisons.
b
P < 0.01;
c
P ¼ 0.051.
PAIN ASSESSMENT IN COGNITIVELY IMPAIRED CHILDREN 263
� 2005 Blackwell Publishing Ltd, Pediatric Anesthesia, 16, 258–265

unique behavior indicative of pain. These included:
unique facial expressions, leg and body activity
including self-stimulating behaviors, specific verb-
alizations and consoling techniques. Interestingly,
several parents noted that a lack of expression,
crying, or responsiveness was most indicative of
pain in their children. Inclusion of these types of
behavior may have contributed to the improved
reliability and validity of FLACC pain scores in this
study. These findings suggest that for children with
CI, a thorough preoperative interview may help to
establish baseline and individual behavior that
facilitate accurate pain assessment during the post-
operative period.
This study evaluated the revised FLACC tool
only in children with acute postoperative pain,
potentially limiting our ability to generalize its use
to other settings. However, studies have identified
pain behavior in children with pain related to
injury, chronic conditions, illness and medical
procedures (23,34,35) that are similar to behavioral
descriptors in the FLACC, attesting to its content
validity in assessing nonsurgical pain. Addition-
ally, the original FLACC tool was validated in
young children with pain of varying etiology,
further supporting its use in nonsurgical popula-
tions (36,37). The difficulty in scoring individual-
ized behaviors might also be considered to be a
limitation. However, the purpose of incorporating
such behavior is to provide guidance to clinicians
in assessment of children who may exhibit unique
behavior. Lastly, our data support the added
reliability of the FLACC tool when these types of
behavior were included.
The FLACC observational pain assessment tool
has been widely used to measure pain intensity in
young children who cannot self-report a pain
score. This study, in conjunction with prior work,
suggests that the FLACC tool provides a reliable
and a valid framework for the assessment of pain
in children with CI. The addition of specific
behavioral descriptors, as well as the incorporation
of parent-identified, individualized behavior, im-
proved the psychometric properties of the FLACC
tool toward improved pain assessment in this
population of children. The tool’s simplicity may
further facilitate easy assimilation into clinical
practice, which may in turn improve clinical
outcomes for children with CI.
Conflict of interest statement
This work does not present any conflict of interest
nor bias for any of the authors.
Acknowledgements
This study was supported by the NIH Grant 5 RO3
HD043920-02. The authors would like to thank Sarah
Earle, BS, Julie Conley, BS, and Melissa Doettl, BS for
their assistance with this project.
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Accepted 5 August 2005
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� 2005 Blackwell Publishing Ltd, Pediatric Anesthesia, 16, 258–265