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Evaluation of Nonpharmacologic Methods of Pain and Anxiety Management for

Laceration Repair in the Pediatric Emergency Department


Madhumita Sinha, Norman C. Christopher, Robin Fenn and Laurie Reeves
Pediatrics 2006;117;1162-1168
DOI: 10.1542/peds.2005-1100

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://www.pediatrics.org/cgi/content/full/117/4/1162

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly


publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
Grove Village, Illinois, 60007. Copyright 2006 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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ARTICLE

Evaluation of Nonpharmacologic Methods of Pain


and Anxiety Management for Laceration Repair in
the Pediatric Emergency Department
Madhumita Sinha, MDa, Norman C. Christopher, MDb, Robin Fenn, PhD, LISWc, Laurie Reeves, CCLSb
aDivision of Pediatric Emergency Medicine, Maricopa Medical Center, Phoenix, Arizona; bDivision of Pediatric Emergency Medicine, Childrens Hospital of Akron, Akron,
Ohio; cCommunity Health Sciences Department, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio

The authors have indicated they have no nancial relationships relevant to this article to disclose.

ABSTRACT
BACKGROUND. Nonpharmacologic interventions, such as distraction, have been

shown to be powerful adjuncts in reducing pain and anxiety in children with both
acute and chronic painful conditions. There are no controlled studies evaluating
these interventions as adjuncts to facilitate completion of painful procedures in the
pediatric emergency department (ED).
OBJECTIVE. We assessed the effectiveness of distraction techniques in reducing the

sensory and affective components of pain among pediatric patients undergoing


laceration repair in the ED.
METHODS. Eligible children between 6 and 18 years of age (N 240) presenting to

the ED for laceration repair were randomly assigned to an intervention or control


arm. Those assigned to the intervention arm were given a choice of age-appropriate distracters during laceration repair. Quantitative measures of pain intensity,
situational anxiety, and pain distress (as perceived by the parent) were assessed by
using the 7-point Facial Pain Scale, State Trait Anxiety Inventory for Children, and
a visual analog scale, respectively, before and after laceration repair. The State Trait
Anxiety Inventory for Children was performed in children 10 years of age.

www.pediatrics.org/cgi/doi/10.1542/
peds.2005-1100
doi:10.1542/peds.2005-1100
Key Words
children, pain, distraction, emergency
Abbreviations
ED emergency department
FPSFacial Pain Scale
VASvisual analog scale
STAICState Trait Anxiety Inventory for
Children
Accepted for publication Sep 6, 2005
Address correspondence to Madhumita Sinha,
MD, Division of Pediatric Emergency Medicine,
Department of Pediatrics, Maricopa Medical
Center, 2601 Roosevelt Ave, Phoenix, AZ
85008. E-mail: postgraduate@cox.net
PEDIATRICS (ISSN Numbers: Print, 0031-4005;
Online, 1098-4275). Copyright 2006 by the
American Academy of Pediatrics

RESULTS. There was no difference in mean change in Facial Pain Scale scores between

the control and the intervention groups in children 10 years of age. Multivariate
analysis in this same age group showed that the intervention was independently
associated with a reduction in pain distress as perceived by parents based on the
mean change in visual analog scale scores. In older children, the intervention was
independently associated with reduction in situational anxiety but not in pain
intensity or in parental perception of pain distress.
CONCLUSIONS. The use of distraction techniques is effective in reducing situational

anxiety in older children and lowering parental perception of pain distress in


younger children. This technique may have a role in improving the quality of
management of procedural pain in a pediatric ED setting.
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SINHA, et al

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HE INTERNATIONAL ASSOCIATION for the Study of Pain


defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is the single most common reason for
seeking acute medical care.1,2 Management of pain in
children has been shown to be inadequate.36 Although a
substantial volume of published information is available
on the pharmacologic approaches to pain management
in the pediatric emergency department (ED), our review
of the literature found no controlled studies evaluating
the application of simple, nonpharmacologic interventions for minimizing procedural pain and situational
anxiety in the pediatric ED. The role of nonpharmacologic techniques, such as distraction and guided imagery,
in alleviating pain and anxiety has been well documented in pediatric oncology patients undergoing frequent invasive medical procedures and also in children
with other recurrent painful conditions.710 Of these,
distraction is the most commonly used nonhypnotic
method for procedural pain of short duration.1113 Distraction is a simple, cognitive behavioral intervention
that diverts attention from a stressful stimulus and focuses it onto a more pleasant one. To be effective, the
distraction technique must be age appropriate, and it
must be appealing to the recipient.14,15 We hypothesized
that use of simple nonpharmacologic interventions, such
as distraction, would reduce the childs pain sensation
and situational anxiety during laceration repair. This
study evaluates the effect of using distraction as an adjunct on the sensory and affective components of pain
during laceration repair among pediatric patients in the
ED.

METHODS
Setting
This study was conducted in the ED of a 253-bed tertiary
care childrens hospital serving a population of 2.5 million in a 17-county service region; the ED evaluates
65 000 pediatric patients annually. All of the patients
presenting with a laceration are evaluated and treated at
the discretion of the medical staff in the ED according to
standard protocol (Table 1). Laceration repair, when
indicated, is done in 1 of 3 private examination rooms
specifically equipped for the completion of minor procedures. The institutional review board of the hospital
approved the study.
Subjects
Children between 6 and 18 years of age visiting the ED
for laceration repair between 12 noon and midnight
were eligible. Children who had sustained an uncomplicated laceration involving only the skin and subcutaneous tissue, 5 cm in length, which could be repaired
using basic suture repair techniques, were enrolled prospectively between October 2003 and August 2004.

TABLE 1 Standard Laceration Repair Technique in the ED


The following steps are involved in the standard laceration repair technique for
uncomplicated laceration repair in the ED
1. Triage nurse examines patient
2. 13 mL of a topical anesthetic gel, a mixture of lidocaine 4%, epinephrine
0.1%, and tetracaine 0.5%, is applied directly over wound, when indicated,
with a cotton-tipped applicator and held with rm pressure for 15 to 30
minutes
3. Patient is escorted to suture room, where resident physician under the
supervision of an ED attending physician or a pediatric emergency
medicine fellow examines wound
4. Wound area is cleaned using standard wound cleansing techniques and
draped by suture staff
5. Supplemental local anesthetic is used for inltration of wound margins
6. If required, wound debridement is done
7. Additional local anesthetic is administered as needed
8. Sutures are placed
9. Wound is dressed and patient is discharged after instructions regarding
wound care and follow-up

Children presenting with multiple lacerations, 1


complex laceration, or a laceration associated with other
injuries were excluded. Patients who were unable to
understand or fully participate in the informed consent
process or study protocol, for whatever reason, were
ineligible for study.
Randomization
The study protocol was reviewed in its entirety with
each of the ED suture program staff and certified child
life workers before implementation. The ED triage nurse
initially examined the patient and applied a topical anesthetic gel, a mixture of lidocaine 4%, epinephrine
0.1%, and tetracaine 0.5%, if indicated; the patient was
then escorted to the suture room. Suture staff identified
eligible participants and, together with the certified child
life worker, obtained written informed consent and assent. Study participants were randomly assigned to a
control or intervention group by a patient allocation
scheme implementing a stratified block design to assure
equal gender distribution in each of the 2 study arms.
Block size varied randomly (from 4 to 8) according to a
schedule prepared in advance and not known to study
personnel. Patient group assignment was determined at
the time of patient enrollment by referring to consecutive sealed envelopes maintained in a dedicated location
in the ED. After group allocation, patients and parents
were asked to complete pain assessment forms. The suture technician then proceeded to clean and drape the
wound and also evaluated the need for supplemental
local anesthetic by checking wound edges for sensation
to pain. If needed, wound edges were infiltrated with
local anesthetic by using a 27-gauge needle.
Intervention
All of the patients, regardless of group assignment, were
evaluated and treated according to standard protocol.
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Children in the intervention group were given a choice


of age-appropriate distracters including music, video
games, or cartoon video. For children who did not show
interest in any of these distracters, the certified child life
worker offered to read a book or help blowing bubbles
during the procedure. A CD player with headphones was
provided for those selecting music distraction, and subjects were given a choice of music. Before and after
laceration repair, patients and their primary parent were
asked to complete standardized study instruments to
assess pain intensity, pain distress, and situational anxiety. To minimize compensatory rivalry and resentful
demoralization in the control group, time allocated to
patients was identical regardless of study group assignment. The experienced ED child life staff explained to
children in both groups what he or she might experience
during the procedure by using developmentally appropriate words and in a nonthreatening manner. ED suture staff and child life staff were trained to carry out the
research protocol, complete data collection forms (before
and after procedure), and instruct patients and their
parent or guardian in the use of scales for measuring
preprocedure and postprocedure pain intensity, situational anxiety, and distress.

Measures for Assessment of Pain and Outcomes


The 7-point Facial Pain Scale (FPS), which is a self-report
scale, was used for quantitative assessment of pain intensity during laceration repair. The 7-point FPS is an
ordinal scale, with scores ranging from 0 (no pain) to 6
(most pain). It has been validated to measure pain intensity in the untrained child in a pediatric ED setting.16
To obtain a quantitative measure of pain distress,
defined as the emotional reaction to the sensory component of pain, an observational visual analog scale
(VAS) was used to measure pain distress as perceived by
the parent or guardian. The horizontal VAS consists of a
100-mm horizontal line with 2 end anchors defining a
scale ranging from no distress to most distress. Parents were asked to rate their perception of their childs
distress, both before and after laceration repair, using the
horizontal VAS.
The State Trait Anxiety Inventory for Children
(STAIC) is a standardized self-report scale used to measure anxiety levels in children. This scale is able to distinguish between transitory anxiety levels (STAIC state
anxiety scale) and general anxiety proneness (STAIC
trait anxiety scale).17 The STAIC state anxiety scale was
used in this study to measure situational anxiety in
children before and after laceration repair. It consists of
20 statements that ask children how they feel at a particular moment in time. The primary outcome measurement was the change in the reported FPS, VAS, and
STAIC scores before and after laceration repair.
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SINHA, et al

Statistical Analysis
Sample size calculation for the regression model with 3
independent variables showed that a minimum of 77
subjects are needed in each group to achieve a power of
80% at a significance level of 0.05 to detect a conventional medium effect size of 0.15.18 Differences between
the intervention and nonintervention groups for demographic characteristics (age, gender, race, and grade in
school) and laceration-related characteristics (duration
of laceration repair, previous suture experience, site of
injury, laceration length, dosage of local anesthetic, and
whether a parent was present) were compared using
independent sample t tests for continuous variables and
2 tests for categorical variables. Change scores for the
FPS, VAS, and STAIC tests were calculated by subtracting the preprocedure score from the postprocedure
score. Because the STAIC was only administered to children over the age of 10 years, all of the analyses were
performed in 2 subgroups of children: children 10
years and children aged 10 years of age. Change scores
for the FPS, VAS, and STAIC tests between the intervention group and the nonintervention group were compared using a nonparametric Mann-Whitney test. To
assess the effect of the intervention on the FPS, VAS, and
STAIC changes scores, multivariate linear regression
analyses were performed. The variables of intervention,
patient ethnicity and age, presence of parent, dosage of
local anesthetic, laceration length, duration of laceration
repair, and study group assignment were considered in
the initial regression models. Because suture duration,
laceration length, and dose of local anesthetic were each
significantly correlated with one another (P .05), the
duration of laceration repair was used as a proxy for
seriousness of wound. Using the variables of age, suture duration, and presence of intervention, reduced
regression models were run to determine the effects of
these variables on FPS, VAS, and STAIC change scores.
For all of the statistical tests, P 0.05 was considered
significant. Statistical analysis was performed using SPSS
12.0 (SPSS Inc, Chicago, IL).
RESULTS
There were 240 patients enrolled in the study, with 120
patients randomly assigned to receive either standard
care or standard care combined with the study intervention. With the exception of laceration length, there were
no statistically significant differences in demographic or
clinical characteristics of patients assigned to either the
intervention or the nonintervention group (Table 2).
Choice of Distracters
Of younger children in the intervention group, 39%
chose music as their distracter followed by videogames
(29%), cartoon videos (27%), bubbles (4%), and books
(2%). Older children in the intervention group chose
music as their distracter (63%) followed by videogames

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TABLE 2 Demographic and Clinical Features of Nonintervention and Intervention Groups


Demographic Information

Age
Male
Race
Black
White
Hispanic
Other race
Grade
05th
6th8th
9th12th
Had previous sutures
Parent was present
Clinical and procedural information
Site of injury
Face
Lower extremity
Scalp
Upper extremity
Trunk
Other
Laceration length, cma
Dose of local anesthetic, cc
Experience of suture technician, y
Had additional local anesthetic
Had systematic analgesia
Suture duration, min
at

Nonintervention Group

Intervention Group

n (%)

Mean

SD

n (%)

Mean

SD

120
60 (50.0)

10.81

3.9

120
60 (50.0)

10.73

3.5

5.13

3.5

2.25
2.52
6.46

1.7
1.9
7.3

26.45

15.9

21 (17.5)
98 (81.7)
0
1 (0.8)
119
69
25
25
57 (47.5)
115 (95.8)
120
55 (45.8)
25 (20.8)
13 (10.8)
25 (20.8)
0
2 (1.6)
119
120
6
7 (5.8)
1 (0.8)
120

3.7

5.00

1.81
2.39
7.98

1.1
1.6
8.8

22.91

12.9

25 (20.8)
92 (76.7)
1 (0.8)
2 (1.6)
120
72
21
27
55 (45.8)
120 (100.0)
120
49 (40.8)
19 (15.8)
18 (15.0)
28 (23.3)
4 (3.3)
2 (1.8)
118
119
6
7 (5.8)
0
120

2.278; P .05.

(21%) and cartoon videos (16%). Overall, music was


the distracter of choice in the majority of cases (52.5%)
followed by videogames (23.4%). Girls were more likely
to listen to music than boys (61% vs 43%; P .002).
Older children were more likely to listen to music than
younger children (63% vs 39%; P .0002). Younger
children chose cartoon videos more frequently compared with older children (27% vs 16%; P .045)
For Children Younger Than 10 Years
Mann-Whitney tests indicated significant differences (P
.01) in VAS change scores between the intervention
and nonintervention groups. Changes in FPS scores be-

tween the 2 groups were not significant (Table 3). Additional analysis showed that, in this age group, there
were no statistically significant differences in the mean
change in FPS and VAS preprocedure and postprocedure
scores between boys and girls.
For children 10 years of age, none of the variables of
age, suture duration, or presence of intervention was
predictive of changes in FPS scores between the preprocedure and postprocedure survey. A regression model,
which included age, duration of laceration repair, and
presence of intervention, performed fairly well to predict
the change in mean VAS score (F 5.94; P .05;
adjusted R2 0.12). In this model, presence of interven-

TABLE 3 FPS Scores and VAS Scores for All Children Younger Than 10 Years
Nonintervention Group (N 57)

Score

FPS
Preprocedure score
Postprocedure score
Change in score
VAS
Preprocedure score
Postprocedure score
Change in score
aP

Intervention Group (N 52)

Mean

95% CI

Range

Mean

95% CI

Range

1.75
0.27
1.48

1.322.18
0.090.45
1.101.86

0.006.00
0.004.00
0.006.00

1.92
0.13
1.79

1.562.28
0.040.23
1.432.15

0.005.00
0.001.00
0.005.00

2.91
1.19a
1.65a

2.353.47
0.711.67
1.132.17

0.008.00
0.005.00
0.007.00

3.31
0.25
3.06

2.643.98
0.110.39
2.423.69

0.0010.00
0.002.00
0.0010.00

.01.

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1165

tion was predictive (P .001) of changes in VAS scores


between preprocedure and postprocedure scores, whereas variables of suture duration and age were not (Table
4).
For Children Aged 10 Years or Older
Using the Mann-Whitney test, changes in STAIC scores
between the intervention and nonintervention groups
were significant (P .001); however, no significant
differences in FPS or VAS scores were noted (Table 5). In
this age group, the variable of presence of intervention
but not those of age and duration of laceration repair
was predictive of changes in STAIC scores. A regression
model including age, duration of laceration repair, and
presence of intervention performed reasonably well to
predict the change in mean STAIC score (F 11.83; P
.001; adjusted R2 0.2; Table 6). In a similar regression
model, none of the variables of age, duration of laceration repair, or presence of intervention was predictive of
changes in VAS scores. In another regression model, the
duration of laceration repair was predictive of change in
the mean FPS score with a coefficient of 0.18 (t 2.04;
P .04); however, this regression model, which included age, duration of laceration repair, and presence of
intervention, failed to predict the change in mean FPS
score (F 2.003; P .12; adjusted R2 0.02; Table 6).
Independent sample t tests failed to reveal statistically
significant differences in the mean change in FPS, VAS,
and STAIC preprocedure and postprocedure scores between boys and girls in this age group.
A total of 11 patients refused to participate in the
study. One patient from the nonintervention group received systemic analgesia. Although it would have been
optimal to exclude him from the study initially, it was
not possible at enrollment to determine how he would
react to pain. However, when this child was removed
from the comparisons of FPS and VAS change scores, the
results of the analysis remained almost identical. This
child was only 8 years of age and was not administered
the STAIC survey. Given this, the results of any analyses
comparing STAIC scores for children aged 10 years
would not be affected. No adverse outcomes were encountered related to use of distraction during this study.
TABLE 4 Predictors of Changes in VAS Scores and FPS Scores in
Children Younger Than 10 Years
Variable

Constant
Age
Suture duration
Intervention
F value
Adjusted R2
aP

.05.

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SINHA, et al

VAS Change Score

FPS Change Score

Regression
Coefcient

Regression
Coefcient

0.03
0.13
0.03
1.38

0.02
0.78
1.78
3.48a

0.78
0.05
0.02
0.25

0.90
0.45
1.45
0.95

5.94a
0.12

1.20
0.01

DISCUSSION
A multimodal, multisystem approach to pain management in pediatric patients has been recommended.19 This
approach recognizes that pain has sensory, emotional,
and behavioral components and that cognitive-behavioral interventions might be useful adjuncts in those
situations where anxiety because of anticipation of pain
plays a key role. In a recently published clinical report on
the relief of pain and anxiety in pediatric patients in the
Emergency Medical Systems, Zempsky et al20 emphasized incorporation of nonpharmacologic stress reduction programs into the Emergency Medical Systems.
Anticipation of pain, separation from parents, loss of
control, and fear of the unknown are some of the factors
associated with increased anxiety during medical procedures among children.21,22 Distress caused by the injury,
anticipation of a painful procedure, and the stressful
environment of an ED makes children and their parents
more vulnerable to anxiety. To our knowledge, no study
evaluating the impact of nonpharmacologic interventions as an adjunct for pain management in a pediatric
ED has been reported previously. Our randomized, controlled study evaluated the effect of distraction on pain
behavior among children during laceration repair in the
pediatric ED. The results indicate that, although the use
of distracters did not reduce self-reported pain intensity
in children during laceration repair, this intervention
was effective in reducing self-reported anxiety associated
with the procedure in older children during laceration
repair in the ED. For younger children, parental perception of pain distress was reduced by the use of distraction.
To be effective, cognitive and behavioral strategies
should invoke a childs imagination, sense of play, and
attention and must be carefully considered so as to be
appropriate to the childs age and developmental abilities.15 A strength of our study was that subjects were
provided a choice of distracters to ensure that the
activity was appealing to them. Kuttner et al8 observed
that whereas in older children passive distraction was
effective, younger children required more interaction
during the process. Similarly, in the present study, all of
the children in the older age group chose a passive
distracter, whereas activities such as book reading and
bubble blowing, where the certified child life worker was
required to be more actively engaged with the child,
were selected by children in the younger age group.
We found that distraction techniques were effective
in reducing parental perception of their childrens distress. In the absence of substantial data on the actual
effect of parental behavior and perception on pain and
anxiety in children, the clinical significance of this finding is unclear. Singer et al23 reported poor agreement
between pain ratings by children, parents, and practitioners; however, this study was limited by a small sample
size, and the authors were unable to conclude which

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TABLE 5 FPS Scores, VAS Scores, and STAIC Scores for Children Aged 10 Years or Older
Nonintervention Group (N 63)

Variable

FPS
Preprocedure score
Postprocedure score
Change in score
VAS
Preprocedure score
Postprocedure score
Change in score
STAIC
Preprocedure score
Postprocedure score
Change in score
aP

Intervention Group (N 68)

Mean

95% CI

Range

Mean

95% CI

Range

2.11
0.49
1.62

1.712.51
0.290.69
1.232.00

0.00 to 5.00
0.00 to 4.00
1.00 to 5.00

2.34
0.37
1.97

1.972.71
0.140.59
1.592.35

0.00 to 6.00
0.00 to 6.00
3.00 to 6.00

3.06
0.86
2.21

2.513.62
0.591.12
1.652.76

0.00 to 9.00
0.00 to 5.00
2.00 to 8.00

3.62
0.82
2.79

3.004.23
0.531.12
2.263.33

0.00 to 9.00
0.00 to 5.00
0.00 to 9.00

36.49
30.41
6.08a

34.7338.25
29.0431.78
4.627.54

20.00 to 53.00
20.00 to 47.00
8.00 to 20.00

39.01
26.72
12.34a

37.1740.95
25.5127.93
10.5214.18

24.00 to 57.00
20.00 to 39.00
0.00 to 29.00

.001.

TABLE 6 Predictors of Changes in STAIC Scores, VAS Scores, and FPS Scores in Children Aged 10 Years or Older
Variable

STAIC Change Score


Regression
Coefcient

Constant
Age
Suture duration
Intervention
F value
Adjusted R2
aP

VAS Change Score


t

3.09a
1.79
0.56
5.24a

10.95
0.42
0.02
6.23
11.83a
0.20

FPS Change Score

Regression
Coefcient

Regression
Coefcient

2.28
0.01
0.01
0.56

1.94
0.19
0.43
1.41

1.44
0.02
0.02
0.28

1.77
0.32
2.04a
1.004

0.84
0.01

2.00
0.02

.05.

assessment best approximates the true degree of pain


experienced by the child. Reduction of parental perception may, indeed, be a valid and measurable outcome in
a pediatric ED with respect to effective pain management.
There are a few limitations in our study. The study
was conducted at a single center with a well-established
suture program, a dedicated staff, and conditions that are
very conducive to offering a standardized intervention as
was required by this protocol. A multicenter study
where resident physicians with different levels of training perform laceration repair would have increased the
generalizability of our results. Another potential limitation was difficulty in blinding the subjects and parents to
the intervention, which may have contributed to reporting bias among parents who observed the procedure.
Also, the possibility of heightened awareness of distraction techniques among the ED personnel during the
conduction of the study could not be excluded, which
may have diminished the differences in the outcomes
between the study group and the control group. Finally,
our study is limited by the potential bias associated with
the use of self-reported measurement scales of pain intensity and anxiety; objective physiological markers,
such as change in pulse rate or body temperature or
neurohormonal mediators, were not studied.24

CONCLUSIONS
The use of distraction techniques was shown to be effective in reducing self-reported anxiety in older children and lowering parental perception of pain distress in
younger children undergoing laceration repair in the
ED. Because cognitive-behavioral interventions, such as
distraction, require minimal training and effort, integrating these techniques into existing pain management
protocols might complement standard pharmacologic
therapy in the pediatric ED and even in other outpatient
settings.
ACKNOWLEDGMENTS
This study was supported by the Ken Graff Young Investigator Grant awarded to Dr Sinha by the Section on
Emergency Medicine, American Academy of Pediatrics.
We thank the emergency department suture and
child life staff at Akron Childrens Hospital for support
and Dr Rashmi Aggarwal for help with tabulation and
data entry.
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Evaluation of Nonpharmacologic Methods of Pain and Anxiety Management for


Laceration Repair in the Pediatric Emergency Department
Madhumita Sinha, Norman C. Christopher, Robin Fenn and Laurie Reeves
Pediatrics 2006;117;1162-1168
DOI: 10.1542/peds.2005-1100
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