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Behavioral pain assessment and


the Face, Legs, Activity, Cry and
Consolability instrument
Terri Voepel-Lewis, Shobha Malviya, Sandra Merkel and Alan R Tait

CONTENTS
Behavioral pain assessment
Characteristics of a
clinically useful pain tool
The FLACC pain tool
Limitations of behavioral
observation of pain

Difficulties assessing pain in individuals who cannot use self-report scales has led to their
exclusion from clinical trials and rendered them vulnerable to undertreatment of pain.
Although several observational pain scales are available for use in these populations,
many lack the characteristics necessary for routine implementation into practice or
research. The Face, Legs, Activity, Cry And Consolability pain scale was developed as a
simple measure of pain intensity in young children. It has been validated in the
postoperative setting in children 27 years of age and children aged 418 years with
varying degrees of cognitive impairment. With minor revisions, the Face, Legs, Activity, Cry
and Consolability pain scale may be useful to assess acute pain across populations of
children and adults who are unable to self-report their pain.
Expert Rev. Pharmacoeconomics Outcomes Res. 3(3), 317325 (2003)

pain assessment must be designed to conform to the communication capabilities of


the suffering person [8].
The difficulty assessing pain in those who
cannot self-report has led to their virtual exclusion from clinical trials related to pain management and rendered them vulnerable to
undertreatment of pain. Indeed, recent studies
have demonstrated that children and adults
with cognitive impairment receive fewer analgesics than cognitively intact individuals
undergoing similar procedures [914]. Furthermore, studies have demonstrated that cognitively impaired individuals complain of and
seek help from pain less frequently than those
who are cognitively intact, despite a high prevalence of pain in this population [5,6,1418].
Care providers must therefore rely on means
other than self-report in order to detect and
adequately treat pain in these populations.

KEYWORDS:
children, cognitively impaired,
FLACC pain tool, measurement
of analgesic efficacy,
pain assessment

Pain assessment is the primary method for


evaluating analgesic efficacy to guide treatment decisions and measure outcome in clinical trials. There is widespread agreement
among clinicians and researchers that selfreport is the gold standard for pain assessment [1,2]. However, many individuals (e.g.,
infants, young children and the cognitively
impaired) are incapable of self-report. The
ability to self-report pain intensity using
rank-order or interval scales, such as 010
visual analog scales (VAS), requires the cognitive skill of understanding such concepts as
magnitude (i.e., which is bigger?) and order
(i.e., seriation; place in order from biggest or
most to smallest or least) [3,4]. Fanurik demonstrated that the majority of cognitively
intact children of less than 7 years of age and
most moderately-to-severely impaired children could not demonstrate the skills necessary to reliably self-report pain intensity [4].
Furthermore, while several studies have demonstrated that some cognitively impaired elderly patients have the capability to identify
the presence of pain, the majority can not
quantify its severity with commonly used
pain scales [57]. This inability to self-report
pain has lead experts to challenge this gold
standard definition of pain and suggest that

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317

Summary & conclusions


Expert opinion
Five-year view
Information resources
Key issues
References
Affiliations

Author for correspondence

Department of Anesthesiology,
CS Mott Childrens Hospital,
University of Michigan Health
Systems, F3900 Box 0211,
1500 E. Medical Ctr. Dr.,
Ann Arbor, MI
48109 0211, USA
Tel.: +1 734 936 0747
Fax: +1 734 763 6651
terriv@umich.edu

Behavioral pain assessment

In the absence of self-report, the observation of


behaviors has been used to identify and quantify pain [1930]. No single behavior provides an
unequivocal measure of pain. Observational
pain scales, therefore, include patterns of distress behaviors that are characteristically associated with pain. Many such tools have been

Voepel-Lewis, Malviya, Merkel & Tait

Table 1. Comparison of behavioral categories and scoring characteristics of commonly cited observational pain scales.
Categories

FLACC [22]

CHIPPS [37]

CHEOPS [30]

TPPPS [25]

RIPS [20]

Facial

X3

Legs

Activity

Cry/vocal

X2

X3

Consolability

X
Posture of trunk

Other

Touching of wound

Sleep
Response to touch

(5 behaviors)

(5 behaviors)

(6 behaviors)

(7 behaviors)

(4 behaviors)

Categories

0-2

0-2

Variable scoring

0-1

0-2 or 3

Total score

0-10

0-10

413

0-7

0-11

Scoring

CHEOPS: Children's Hospital of Eastern Ontario Pain Scale (only the behavioral components have been included here); CHIPPS: Children and Infants Postoperative Pain
Scale; FLACC: Face, Legs, Activity, Cry and Consolability; RIPS: Riley Infant Pain Scale; TPPPS: Toddler-Preschooler Postoperative Pain Scale; X: Indicates the tool contains an
item; X2: Indicates that the tool contains two items; X3: Indicates that the tool contains three items.

demonstrated to be valid and reliable and several have been used


to evaluate analgesic efficacy in clinical trials [19,20,22,2540].
While observational tools differ in content and style, all incorporate facial expression and vocalization categories, and most
assess posture, movement or positioning. Some tools assess
social interaction or consolability and others incorporate physiologic changes or assessment of breathing patterns
[22,26,27,30,35,36,41]. Bttner and Finke evaluated 16 behaviors in
young cognitively intact children and demonstrated that five,
including crying, facial expression, posture of the trunk, posture
of the legs and motor restlessness, were reliable, specific and sensitive in predicting analgesic requirements [37]. Observational
pain tools should, therefore, minimally incorporate these five
behavioral categories in order to capture the most reliable pain
behaviors. TABLE 1 presents several commonly cited observational
pain scales and a description of their categories.
Several recent studies have yielded qualitative descriptors of
pain behaviors common to adults and children with cognitive
impairment, which are similar to those described for cognitively
intact children [19,23,29,4253]. These include: vocal expressions
(e.g., moaning, crying, screaming or yelling), nonco-operation
or irritability, facial expressions (e.g., frowning, eyes closed
tight), activity (not moving, less active) and various bodily
expressions (e.g., stiff, spastic, tense or rigid; flinching or movement of body part away; arched head, or curls up). The cognitively impaired may additionally exhibit unusual pain behaviors,
such as fidgeting, anger, aggressiveness or self-injury
[18,29,48,54,55]. Despite a large body of literature describing such
pain behaviors, relatively few behavioral observational tools have
been developed for use in the cognitively impaired [19,28,31,51].
Furthermore, few tools have been evaluated for their validity or
reliability in this population and most lack some or all of the
qualities necessary for clinical utility. TABLE 2 presents the characteristics of and the behavioral categories included in several tools
that have been evaluated in the cognitively impaired.
318

Characteristics of a clinically useful pain tool

The usefulness of a pain tool for use in the clinical or research


setting is dependent upon several characteristics, the most
important of which are validity and reliability [56]. Measures of
validity attest to a tools ability to measure what it is intended to
measure, whereas reliability demonstrates the consistency, stability or reproducibility of the measurement [56]. The reproducibility of behavioral pain scores is generally evaluated by determining the interobserver reliability using measures of
association and exact agreement. Testretest is another method
used to establish reliability when videotaped observations are
available [31].
In contrast, several measures are important in order to establish
the validity of a pain tool. The most basic form is content validity,
or how well the items on the scale represent the construct of pain,
as described in the literature and/or based on expert opinion. As
mentioned, several behaviors have been shown to be reliably associated with pain in groups of nonverbal children and adults. The
inclusion of such behaviors in an instrument supports the tools
overall content validity. Criterion validity is the relationship
between the measurement of interest and the gold standard for
pain measurement. Since self-report remains the gold standard of
pain assessment, many studies have compared the new measure of
pain against self-reported pain scores, such as the VAS 010 numbers scale or, in the case of children, the FACES scale [57]. In studies of children or individuals who cannot self-report, however, the
nurses global pain ratings, caregiver or parent assessments and
other behavioral observational measures have been used as criteria
against which new scales have been compared [19,21,22,31]. While
each of these criteria poses limitations, their widespread use in the
absence of a true gold standard for these populations supports this
methodology.
Several methods have been used to evaluate the construct validity of pain tools, which is the degree to which the measurement is
measuring pain versus some other construct. Comparison of pain
Expert Rev. Pharmacoeconomics Outcomes Res. 3(3), (2003)

Behavioral pain assessment & FLACC assessment

scores before and after a potent analgesic, or before and during a


painful stimulus (e.g., injection), is a commonly used method
[22,31]. Comparing pain scores between extreme groups (i.e., no
pain group vs. pain group) is another acceptable method [19].
Lastly, predictive validity provides an estimate of the sensitivity
and specificity of a measure. Previous studies that have evaluated
sensitivity and specificity of pain tools are open to interpretation,
largely due to inconsistencies in the definition of true pain
[19,20,37]. For instance, in two studies analgesic requirements were
used to differentiate clinically significant pain such that subjects
who required an analgesic were considered to have pain [20,37].
Another study used caregiver assigned pain scores to indicate
whether true pain was present or not [19]. In this same regard, several studies have defined clinically significant self-reported or
behavioral pain scores to be greater than 30 out of 100, or 3 out of
10, as these scores were associated with analgesic demand [37,58].
Another study that showed that moderate pain (i.e., mode of 3 on
a 06 self-reported FACES scale) was consistent with a childs
treatment threshold (i.e., desire for pain medication) [59]. The
interpretation of true pain, then, may vary depending on which
type of tool is used. In the absence of self-report, the evaluation of
a tools sensitivity is subject to the investigators expert opinion
and, as such, may be more of an approximation. Sensitivity and
specificity of a pain tool, therefore, remain imprecise measures of
the tools validity.
Although reliability and validity are important features that
describe the tools accuracy, there are other features necessary for
easy and appropriate assimilation into practice. Feasibility is the
extent to which the pain tool can be implemented in clinical
practice, whereas utility indicates its usefulness as a measure of
pain within or across populations in a particular setting [56]. Clinical feasibility and utility are, in general, dependent on the tools
content and structure. Previous investigators have identified several attributes necessary for easy implementation into practice
[60,61]. These include the tools relative advantage compared with

others, its compatibility or similarity to other tools already in


place and its complexity [60,61]. Additionally, the ability to use one
tool across populations may improve its clinical utility [37]. These
pragmatic qualities are important to facilitate implementation,
however, the structure and economy (i.e., fewest items) of an
observational system have been shown to influence its reliability
and sensitivity in detecting pain [37]. If the number of items on a
scale is too high it becomes complicated and impractical, yet too
few items may reduce its reliability, sensitivity and specificity [37].
Preston and colleagues found that increasing the number of categories in an ordinal scale beyond seven did not substantially
improve its reliability and that scales with three- and five-points
were the quickest and easiest to use [62]. Pain tools that have pragmatic qualities yet remain sensitive and reliable in measuring pain
are the most useful, since they may be readily integrated in the
clinical and research settings.
The Faces, Legs, Activity, Cry & Consolability pain tool

The Face, Legs, Activity, Cry and Consolability (FLACC) pain


tool is an observational scale that scores each of five behaviors on
a 02 point scale, to provide an overall pain score ranging from
010 (TABLE 3) [22]. The FLACC was developed at the University
of Michigan, Ann Arbor, MI, USA, as a simple measure of pain
behaviors possessing the attributes necessary to facilitate easy
assimilation into clinical practice. For instance, the total score
can range from 010, which is consistent or compatible with
most self-report measures commonly used in practice and
research. The inclusion of only five categories, each scored consistently from 02, makes the tool relatively less complex than
others. Furthermore, the acronym FLACC facilitates recall of the
behavioral categories to be assessed, contributing to its pragmatic
qualities. Indeed, the FLACC tool has been incorporated as a
standard pain assessment tool for young children in many settings in the USA and internationally, and has been successfully
used to evaluate analgesia in several pain studies [39,40,6368].

Table 2. Description of behavioral pain tools evaluated in cognitively impaired populations.


FLACC [22]
Categories Face
Legs
Activity
Cry
Consolability

Scoring

010

Utility

Children/CI
Acute pain

UAB [51]

DS-DAT [28]

NCCPC-PV [19]

NAPI [20]

Vocal complaintsverbal
Vocal complaintsnonverbal
Down-time
Facial grimaces
Standing posture
Mobility
Body language
Use of supportive equipment
Stationary movement
Medication use

Noisy breathing
Negative vocalization
Content facial expression
Sad facial expression
Frightened expression
Frown
Relaxed body language
Tense body language
Fidgeting

Vocal
Social
Facial
Activity
Body/limbs
Physilolgical signs

Verbal/vocal
Body movement
Facial
Respose to touch

010

027

081

011

Elderly,
chronic pain

Elderly with demintia, general CI


discomfort

acute pain

Young childern
incomplete testing
in CI

CI: Cognitively impaired; DS-DAT: Discomfort ScaleDementia Alzheimer's Type; FLACC Face, Legs, Activity, Cry And Consolability; NAPI: Nursing Assessment of Pain
Intensity; NCCPC-PV: Noncommunicating Children's Pain Checklistpostoperative Version; UAB: University of Alabama Pain Scale.

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319

Voepel-Lewis, Malviya, Merkel & Tait

Table 3. Face, Legs, Activity, Cry and Consolability (FLACC) observational pain scale [22].
Score
Face

0 = No particular expression or smile


1 = Occasional grimace/frown, withdrawn or disinterested
2 = Frequent/constant quivering chin, clenched jaw

0
1
2

Legs

0 = Normal position or relaxed


1 = Uneasy, restless, tense
2 = Kicking or legs drawn up

0
1
2

Activity

0 = Lying quietly, normal position, moves easily


1 = Squirming, shifting back and forth, tense
2 = Arched, rigid or jerking

0
1
2

Cry

0 = No cry
1 = Moans or whimpers, occasional complaint
2 = Crying steadily, screams or sobs, frequent complaints

0
1
2

Consolability

0 = Content and relaxed


0
1 = Reassured by occasional touching, hugging or being talked to, distractable 1
2 = Difficult to console or comfort
2

Reprinted from Pediatric Nursing 23(3), 294 (1997) with permission from the publisher, Jannetti Publications, Inc., East Holly Ave Box 56, Pitman, NJ, 08071 0056 USA,
Tel.: +1 856 256 2300, Fax: +1 856 589 7463. For a sample copy of the journal, please contact the publisher.

The FLACC pain assessment tool contains those core behavioral categories that have been reliably associated with pain in
infants, young children and in the cognitively impaired, attesting
to its general content validity. The tool has been evaluated against
several criteria in previous studies of children during their early
and later (i.e., in patient) postoperative recovery periods [22,31,57].
In a study of 89 cognitively intact children aged 27 years of age,
the FLACC was found to have excellent correlations with the
Observational Pain Scale (OPS) (r = 0.8; p < 0.001) and significant but lower correlations with the bedside nurses global ratings
of pain using the VAS (r = 0.41; p < 0.005) [22]. In another study
of 30 cognitively intact children aged 37 years, FLACC scores
were compared to the childrens self-reported FACES scores [57].
The correlations between FLACC and FACES scores for all children were moderate but significant (r = 0.58; p = 0.001) and
were better in children aged 57 years (r = 0.83) compared with
those of less than 5 years of age (r = 0.25). None of the children
in this study, however, were tested for their ability to use selfreport scales. The FACES scores from the younger children may,
therefore, have been unreliable. Lastly, FLACC scores were compared with parent-reported VAS scores for 113 observations in
79 cognitively impaired children aged 418 years of age [31]. Correlations were significant, ranging from 0.50.7, suggesting moderate criterion validity. In this study, parent scores tended to be
higher than FLACC scores assigned by video observers blinded
to treatment and procedure and, to a lesser degree, bedside nurses
(overall bias + 0.59, precision 2.3).
Construct validity of the FLACC has been tested in both cognitively intact young children and in the cognitively impaired,
by comparing scores before and after analgesics [22,31]. In earlier
studies, observers scores decreased significantly following analgesics (7 2.9 vs. 1.7 2.2; p < 0.001), however, these nurses were
not blinded to analgesic administration. In the recent study of

320

children with cognitive impairment, nurses blinded to analgesic


administration viewed videotaped observations and assigned
FLACC scores. There was a significant decrease in FLACC
scores following analgesics (5.3 2.8 vs. 2.0 2.4, p 0.001),
supporting the construct validity of the tool.
Previous studies have not evaluated the predictive validity of
the FLACC. However, the recent study in children with cognitive impairment did report analgesic administration in children with pain scores coded as none to mild, or FLACC scores
of 03, compared with those with moderate-to-severe pain, or
FLACC scores of greater than three [31]. Of those with scores
of 03, 64% received no medication and 18% received a nonopioid, whereas 60% with moderate-to-severe pain received an
opioid analgesic. Although the presentation of these data did
not make any claims regarding the sensitivity or specificity of
the FLACC, the data do suggest that FLACC scores of greater
than three reflect clinically significant pain, which is similar to
studies of other 010 pain tools [37,58].
The reliability of the FLACC scores has been tested in previous studies using two methodologies. Inter-rater reliability was
evaluated by correlating FLACC scores assigned simultaneously
by observers and by measures of exact agreement between raters
[22,31]. The earlier study evaluating reliability in cognitively
intact children demonstrated good to excellent correlations for
total scores (r = 0.94; p < 0.001) and good to excellent agreement for scores in each of the categories (6991% agreement,
Kappa values 0.520.82) [22]. Inter-rater reliability and exact
agreement were lower in the second study, which examined the
tool in cognitively impaired children [31]. Correlations between
the bedside nurses and blinded video observers total FLACC
scores were high (r = 0.778; p < 0.001), however, those for each
of the categories ranged from low (activity and legs categories)
to high (face and cry categories). Measures of exact agreement

Expert Rev. Pharmacoeconomics Outcomes Res. 3(3), (2003)

Behavioral pain assessment & FLACC assessment

for each of the categories were also variable. Although some of


the comparisons reached acceptable levels of agreement, there
was least agreement in the legs and activity categories (exact
agreement = 1788%, Kappas 0.210.48). FLACC and parent
VAS scores were coded as none-to-mild (scores 03), moderate
(scores 46) and severe (scores 710) to assess reliability for
scores that, in general, guide treatment. There were moderate
to high correlations between all observers (r = 0.550.75;
p < 0.001) and exact agreement ranged from 2492% (Kappas
0.40.6). Testretest reliability of the FLACC for each of the
blinded video observers was supported by excellent correlations
for total scores (r = 0.800.88; p < 0.001) and for scores in each
of the categories (r = 0.60.9; kappas 0.40.9; p < 0.001).
These data support the reliability and validity of the FLACC,
particularly in young children. However, minor modifications
may be required to improve the reliability of the tool in scoring
pain for the cognitively impaired. The categories of legs and
activity had poorer agreement than others, which may have
been partially attributed to limitations imposed by the videotaped observations. Breau and colleagues similarly found a
lower reliability in the subscales of body and limbs categories
on the Noncommunicating Childrens Pain Checklist-Postoperative Version [19]. Physical disabilities, spasticity, dystonia and
dysmorphia, that are common to children with cognitive
impairment, may hinder behavioral observational assessment of
pain in this population, reducing the reliability of certain observations (e.g., legs and activity). Furthermore, children and
adults with cognitive impairment often exhibit idiosyncratic
pain behaviors [50,5255,69,70]. It is therefore important to consider the childs baseline and individual pain behaviors when
assessing pain indicators. Parents or primary caregivers can
assist with interpretation of these behaviors.
Limitations of behavioral observation of pain

Pain behaviors are not always specific to pain and in many


cases indicate another source of distress. Young children and
infants exhibit similar behaviors when they are anxious, scared
or hungry. Additionally, agitation and associated behaviors
may indicate a number of physiologic distressors, such as respiratory compromise or drug reactions, particularly in infants,
children with underlying respiratory conditions and the cognitively impaired. Observational pain scores from tools, such as
the FLACC should, therefore, provide only one component of
pain assessment. The context of behaviors in view of the
patients medical and surgical history and analgesics administered, must be considered when making treatment decisions
using behavioral pain scores. Furthermore, consideration of
physiologic parameters, the parents or caregivers opinion and
the use of expert professional judgment may help to guide
treatment decisions.
Most behavioral observation tools, including the FLACC, are
meant to score the intensity of acute pain, such as that observed
in the postoperative period. Studies have suggested that acute
distress behaviors lessen over time even though pain may persist. Withdrawn and disinterested expressions and immobility
may replace grimacing, crying and motor restlessness seen as

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initial responses to pain. This may explain some of the discordance between self-reported and behavioral pain scores described
in previous studies. Additionally, the behavioral reaction to
long-term pain has been described as more similar in manifestation to depression. Assessment of chronic pain requires the consideration of several other behavioral patterns, such as sleep
quality, appetite and psychological manifestations. Other available pain tools may provide a more reliable assessment of
chronic pain compared with simple behavioral scales, such as
the FLACC [71].
It is important to note that behavioral pain tools are meant
to score the intensity of pain. There are several dimensions of
pain sensation that must be incorporated into pain assessment.
The qualities of the pain, its location, duration and frequency
have important implications for appropriate diagnoses and
selection of effective pain treatments. Comprehensive pain
assessment must include these dimensions in addition to
assessment of intensity.
Lastly, behavioral observation should be reserved for scoring
pain in those who cannot self-report. Young children and the
cognitively impaired often can identify the presence of pain
(i.e., yes/no) and can discriminate pain intensity using a small
number of options (i.e., three to four choices) [3]. For these
individuals, selecting the appropriate self-report tool, such as
one with a limited number of options, may provide the best
method for pain assessment. When the reliability of self-report
remains questionable, however, information obtained from
behavioral observation and from other sources, such as physiologic parameters or parental input may provide convergent data
on which to base treatment decisions.
Summary & conclusions

The observation and scoring of pain behaviors is currently the


best method available to assess pain in individuals who cannot
verbalize or self-report their pain. While several observational
tools are available for use in clinical practice and research, many
do not possess the qualities necessary for clinical feasibility or
utility. The FLACC has met several tests of reliability and validity in young children and in the cognitively impaired. Furthermore, the structure of this tool meets several important requirements for ease of implementation into clinical practice. Studies
to date support the use of the FLACC across populations of children who cannot verbalize their pain, particularly in the absence
of better assessment tools. Further study and evaluation of the
FLACC in groups, such as the cognitively impaired elderly may
also increase its utility across other populations.
Expert opinion

The past decade has seen many advances in pain assessment


and management strategies for infants and young children, yet
certain populations remain at risk for the undertreatment of
pain. The recent proliferation of pain-related studies in the
cognitively impaired demonstrates a promise towards the
advancement of pain management practices for this vulnerable
population. Difficulties with pain assessment should no longer
pose a barrier towards effective management in individuals

321

Voepel-Lewis, Malviya, Merkel & Tait

who cannot self-report their pain. Incorporation of frequent


and routine pain assessment using tools, such as the FLACC,
can improve the ability to effectively manage pain in nonverbal
individuals.
There is widespread and general agreement that relief from
pain is a basic right of all individuals who seek or require
healthcare, regardless of whether or not they can verbalize its
presence. However, despite the increase in the number of
scales available to assess and relieve pain, their implementation into routine practice remains slow. We agree with investigators who suggest that poor utilization of research findings is
generally the result of perceived relevancy, provider burden
and difficulties with routinization. For example, tools that are
available to assess pain in nonverbal patients have not been
incorporated into routine practice, perhaps due to their perceived complexity, or lack of relevancy for the populations
cared for in the clinical setting. The FLACC tool may be
more readily incorporated into practice due to its many pragmatic qualities, as well as its relevancy across populations.
Some would argue that the tool lacks all of the necessary
validity and reliability testing in specific settings, such as the
intensive care unit. However, until further refinements and
testing of the FLACC become available and in the absence of
a better tool, the FLACC in its present form has been shown
to possess sufficient psychometric properties to be useful in
guiding clinical practice.
Hester and colleagues identified the illusion of certainty as a
unique problem that must be overcome in the area of observational pain assessment [60]. This term refers to the nurses perception of how much pain the individual is experiencing
without actually measuring it. This perception leads to assignment of an observational pain score that matches the nurses
global assessment. The use of a 010 scale, such as the
FLACC, may actually promote this type of rote assessment,
where the nurse does not score each category individually but
assigns an overall number that is, in reality, her global assessment. This potential misuse of pain scales may persist unless
specific requirements for documentation are put into place,
such that each item must be scored separately. To our knowledge, this requirement has been built into at least one system
for computerized documentation of pain assessment [101].
Five-year view

Given the recent standards from the Joint Commission on


Accreditation of Healthcare Organizations, we expect to see a
fairly rapid extension of pain assessment to include all individuals in all types of settings [72]. The inability of a patient to verbalize or self-report pain no longer precludes the clinicians
pain assessment, particularly since many pain tools are now
available to facilitate this assessment. Methods that promote
easy integration into routine practice will be those that are
used most widely. Our experience and collegial interactions
suggest that, given its pragmatic qualities, the FLACC is a tool
that can be widely-integrated to assess pain in populations
unable to self-report.

322

In view of recent regulations from the National Institutes of


Health and in response to the Federal Drug Administration
Modernization Act which requires data in pediatric patients
prior to submitting new drug applications with pediatric labeling, the inclusion of children, cognitively impaired and the
elderly in clinical drug trials will expand [102,103]. The availability of reliable and valid methods to assess pain in these populations should facilitate and promote the inclusion of these vulnerable groups in analgesic trials. The FLACC tool has been
successfully used to evaluate therapeutic end-points of analgesics in studies in young children and in the cognitively
impaired. The inclusion of nonverbal populations in future
analgesic trials may be further facilitated by incorporating the
FLACC as an outcomes measure.
Currently, the cognitively impaired remain susceptible to
poor assessment and undertreatment of pain, despite the
recent increased awareness of their vulnerability. Expected
improvements in routine pain assessment and the inclusion
of these populations in clinical trials should lead to rapid
advances in pain management. Over the next 5 years, children and adults who cannot complain of their pain can
expect the same treatments and comforts experienced by
those who complain most vocally.
Lastly, the number of studies evaluating the FLACC and
other pain assessment measures for the nonverbal will increase
during the next 5 years. The FLACC may require minor modification and further evaluation in cognitively impaired children
and needs to be evaluated for use in the cognitively impaired
elderly. Additionally, evaluation of the FLACC as a pain assessment measure in nonverbal, mechanically ventilated patients in
the intensive care unit will provide further data of its utility
across populations. However, the basic structure of the
FLACC, with its five categories will remain consistent, since
these provide a simple acronym for pain behaviors that are valid
across populations.
Key issues
Frequent and routine pain assessment improves the ability to
effectively manage pain.
The observation and scoring of pain behaviors is currently
the best method available to assess pain in individuals who
cannot verbalize or self-report their pain.
The Face, Legs, Activity, Cry And Consolability (FLACC) was
developed as a simple measure of pain behaviors possessing
the attributes necessary to facilitate easy assimilation into
clinical practice.
The FLACC has been shown to be reliable and valid in young
cognitively intact children and in cognitively impaired
children aged 418 years.
The FLACC may be a clinically useful tool to assess acute pain
and guide practice across several populations that cannot
self-report pain.

Expert Rev. Pharmacoeconomics Outcomes Res. 3(3), (2003)

Behavioral pain assessment & FLACC assessment

Information resources

Voepel-Lewis T, Merkel S, Tait AR, Trzcinka A, Malviya S.


Reliability and validity of the FLACC observational tool as a
measure of pain in children with cognitive impairment.
Anesth. Analg. 95, 12241229 (2002).
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The
FLACC: a behavioral scale for scoring postoperative pain in
young children. Pediatric Nursing 23, 293297 (1997).
Breau LM, Finley GA, McGrath PJ, Camfield CS. Validation
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Beyer JE, McGrath PJ, Berde CB.


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Terri Voepel-Lewis, MSN, RN, Clinical Nurse


Specialist, Department of Anesthesiology,CS
Mott Childrens Hospital, University of
Michigan Health Systems, F3900 Box 0211,
1500 E. Medical Ctr. Dr., Ann Arbor, MI
48109 0211, USA, Tel.: +1 734 936 0747,
Fax: +1 734 763 6651, terriv@umich.edu
Shobha Malviya, MD, Associate Professor,
Department of Anesthesiology, C.S. Mott
Childrens Hospital, University of Michigan
Health Systems, F3900 Box 0211, 1500 E.
Medical Ctr. Dr., Ann Arbor,
MI 48109 0211, USA
Sandra Merkel, MS, RN, Clinical Nurse
Specialist, Department of Anesthesiology, CS
Mott Childrens Hospital, University of
Michigan Health Systems, F3900 Box 0211,
1500 E. Medical Ctr. Dr., Ann Arbor, MI
48109 0211, USA
Alan R Tait, PhD, Associate Professor,
Department of Anesthesiology, CS Mott
Childrens Hospital, University of Michigan
Health Systems, F3900 Box 0211, 1500 E.
Medical Ctr. Dr., Ann Arbor,
MI 48109 0211, USA

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