Published online April 3, 2006
PEDIATRICS
Vol. 117
No. 4
April 2006, pp.
1162-1168
(doi:10.1542/peds.2005-1100)
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 and
Laurie Reeves, CCLSb
a Division of Pediatric Emergency Medicine, Maricopa Medical Center, Phoenix, Arizona
b Division of Pediatric Emergency Medicine, Children's Hospital of Akron, Akron, Ohio
c Community Health Sciences Department, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio
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ABSTRACT
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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.
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.
Key Words: children • pain • distraction • emergency
Abbreviations: ED—emergency department • FPS—Facial Pain Scale • VAS—visual analog scale • STAIC—State Trait Anxiety Inventory for Children
The 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.3–6 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.7–10 Of these, distraction is the most commonly used nonhypnotic method for procedural pain of short duration.11–13 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 child's 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.
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METHODS
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Setting
This study was conducted in the ED of a 253-bed tertiary care children's hospital serving a population of 2.5 million in a 17-county service region; the ED evaluates 
65000 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.
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. 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 child's 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.
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).
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RESULTS
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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 (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 between 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 intervention 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 ß 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.
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DISCUSSION
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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 child's imagination, sense of play, and attention and must be carefully considered so as to be appropriate to the child's 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 children's 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 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
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CONCLUSIONS
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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.
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ACKNOWLEDGMENTS
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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 Children's Hospital for support and Dr Rashmi Aggarwal for help with tabulation and data entry.
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FOOTNOTES
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Accepted 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{at}cox.net
The authors have indicated they have no financial relationships relevant to this article to disclose.
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PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics
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