Issues in Comprehensive Pediatric Nursing, 32:65 76, 2009 Copyright Informa Healthcare USA, Inc.

. ISSN: 0146-0862 print / 1521-043X online DOI: 10.1080/01460860902737418 ATRAUMATIC CARE: EMLA CREAM AND APPLICATION OF HEAT TO FACILITATE PERIPHERAL VENOUS CANNULATION IN CHILDREN Lori Huff, BSN, RN, CCRN Annette Hamlin, BSN, RN Diane Wolski, BSN, RN Tracy McClure, BSN, RN Aris Beoglos Eliades, PhD, RN Akron Children s Hospital, Akron, Ohio Laurie Weaver, BSN, RN Wooster Community Hospital, Wooster, Ohio Deb Shelestak, PhD, RN Kent State University, Stark Campusm, North Canton, Ohio 65 The purpose of this study was to investigate whether the application of heat placed to a child s potential intravenous (IV) site after the application of EMLA Cream decreases vasoconstriction, therefore promoting atraumatic care in the hospitalized pediatric patient. Venipuncture in children is a painful and frequently performed procedure. While use of EMLA Cream to reduce pain on insertion is a common practice with pediatric patients, no studies had measured venous size in relation to EMLA Cream and heat application. A descriptive quantitative design was used to examine the use of EMLA Cream and application Received 24 October 2008; accepted 9 January 2009. Partial funding provided by Akron Children s Hospital, Pediatric Nursing Research Grant. We thank Kristine Gill, PhD, RN, Emeritus Faculty, College of Nursing, The Universi ty of Akron, Ohio for assistance with manuscript preparation. Address correspondence to Lori Huff, 6200 Education Coordinator, Akron Children s Hospital, One Perkins Sq., Akron, Ohio, 44308. E-mail: lhuff@chmca.org

L. Huff et al. of heat to facilitate venipuncture for peripheral venous cannulation. A convenience sample of 30 hospitalized Caucasian children, eight to twelve years old, participated. Vascular ultrasound directly measured the vein prior to and 1 hour after EMLA Cream 2 minutes after heat application. Mean vein measurements were 0.243 cm prior to EMLA Cream , 0.205 cm after EMLA Cream applied for 1 hour, and 0.253 cm after two minutes of heat. There was a significant increase in vein visualization from pre-application of heat to post application of heat with a success rate of 80% with the first time attempt of IV insertion. Therefore, application of heat counteracts the adverse effect of vasoconstriction that occurs with EMLA Cream application, potentially increasing peripheral venous cannulation success rates. Keywords: Atraumatic care, Venipuncture, Emla Cream, Heat application, Children, Pediatrics Venipuncture in children is recognized by nursing and child-life specialists to be one of the most painful and frequently performed invasive procedures instituted by nurses. In an era when atraumatic care is of great concern, the application of Eutectic Mixture of Local Anesthetic (EMLA) Cream to the venipuncture site is a common practice in pediatric hospitals and clinics. EMLA Cream is known to cause initial blanching and vasoconstriction, which may hinder successful intravenous catheterization (Arildsson, Nilsson, & Stromberg, 2000). At the study hospital, nurses noticed that when they used EMLA Cream there was a white cloud that would form at the site, making it difficult to visualize the vein. Instead of one venipuncture, it often would take multiple attempts to successfully insert an IV. Thus, what was supposed to be an atraumatic procedure became a traumatic one. THEORETICAL FRAMEWORK The framework used for this research study was Donna Wong s Conceptual Model of Atraumatic Care. Atraumatic care is the provision of therapeutic care utilized in healthcare settings that eliminates or minimizes the psychological and physical distress experienced by children and families (Hockenberry & Wilson, 2007). Wong identified three principles that provide the framework for atraumatic care. The first is to prevent or minimize the child s separation from the family. The second is to promote a sense of control, and the third is to prevent or minimize bodily injury and pain (Hockenberry & Wilson, 2007). The application of EMLA Cream does prevent or minimize the pain caused by intravenous (IV) insertion. The goal of this research was to minimize the bodily injury and pain by application, as well as

Venipuncture in Children counteracting the vasoconstriction from the EMLA Cream , thereby decreasing the number of venipuncture attempts. BACKGROUND The literature indicates that studies such as those conducted by Morrison, et al. (1998) validated venipuncture as one of the most traumatic hospital procedures. In this study, 165 patients ranging in age from 20 to 100 years old were asked to rate the pain of sixteen common hospital procedures. Venipuncture ranked fourth of sixteen procedures listed; only drawing an arterial blood gas, inserting a nasogastric tube, or placing a central line exceeded intravenous insertion. Kleiber et al. (2007) stated that children reported significant pain during peripheral intravenous cannulation despite the use of topical anesthetic. In addition, other studies acknowledged placement of IV catheters as a painful and stressful procedure for children (Jimenez, Bradford, Seidel, Sousa, & Lynn, 2006; Tak & van Bon, 2006). Since venipuncture has been recognized as a painful procedure, interventions that lessen the pain, such as EMLA Cream , have been used clinically. The effectiveness of EMLA Cream and other topical anesthetic creams has been validated in several research studies performed on children receiving venipuncture. For example, Koh, Fanurik, Stoner, Schmitz, and VonLanthen (1999) reported that parental application of EMLA Cream at home appeared to be as effective as clinician application in reducing children s pain and distress associated with IV insertion. Kleiber and associates (2002) compared EMLA Cream and ELA Max application for venipuncture in children and found no significant difference in pain ratings and difficulty in vein cannulation, with both reducing pain for successful IV insertion. Tak and van Bon (2006) compared the effect of EMLA Cream and a placebo cream on the reported pain and observed distress associated with venipuncture in children. Their results concluded that EMLA Cream reduced pain from venipuncture (Rogers & Ostrow, 2004). A disadvantage of EMLA Cream has been the resulting the skin, causing decreased vein visualization (Liu, 2003). Bjerring, Anderson, and Arendt-Nielsen (1989) Cream caused initial blanching and vasoconstriction blanching of Kirchner, & Petrack, reported that EMLA maximally after

1.5 hours of application in adults. Arildsson, Asker, Salerud, and Stromberg (2000) performed a study using 12 subjects to assess the changes in the appearance of superficial skin capillaries and skin microvascular perfusion. In their comparison of different lengths of time of EMLA Cream application, they found that longer application prolonged hyperemia. In addition , Lenhardt, Seybold, Kimberger, Stoiser, and Sessler (2002) discovered that by locally warming the venipucture site prior to insertion, the time and

L. Huff et al. number of venipuncture attempts was reduced. Haggblad, Larsson, Arildsson, Stromberg, and Salerud (2001) investigated the effect of heat application on vessel size. The study assessed the effects of heat on analgesized skin in 12 Caucasian males and females, ages 21 32 years. It was determined that increased blood flow occurred in the deeper lying skin vessels, but not the capillaries, when heat was applied. None of these studies examined the vessel size with heat in combination with EMLA Cream . Liu et al. (2003) explored the use of EMLA Cream application and heat for a time frame of 60 minutes. This randomized, double-blinded clinical trial used healthy adult subjects to compare the degree of pain of intravenous catheterization at 20 and 60 minutes after application of EMLA Cream with heat, EMLA Cream without heat, or placebo without heat (Liu et al., 2003). The goal of this study was to determine whether the addition of heat to EMLA Cream shortened time of onset for effective analgesia. The researchers found that applying EMLA Cream for 20 minutes with heat provided moderate analgesia, measured by a 100mm visual analog scale, and that the manufacturer s recommended time of 60 minutes remained superior for sufficient analgesia. (Liu et al. 2003). No studies using adults or children have examined the combined effectiveness of heat after EMLA Cream application on vein size, vein visibility, the child s pain level, or rate of first-attempt venipuncture. The purpose of this study was to investigate whether the application of heat placed to a child s potential intravenous site after the application of EMLA Cream decreases vasoconstriction, therefore promoting atraumatic care in the hospitalized pediatric patient. DESIGN AND METHOD Design A descriptive, quantitative design was used to explore the use of EMLA Cream and application of heat to facilitate peripheral venous cannulation. Setting/Sample The study was conducted at a 250-bed pediatric hospital that provides care of children from birth through teenage years, and serves a population of 2.5 million in northeastern Ohio. The convenience sample consisted of 30 Caucasian children ranging in age from 8 to 12 years, with medical or surgical diagnoses requiring IV insertion and who were hospitalized on the school-age unit at a children s hospital. The sample was limited to Caucasian children to decrease variation in visibility of the vein that may

Venipuncture in Children result from skin color. Children with mental disability were excluded due to the challenge of trying to obtain consent/assent, and the inability of the child to communicate the pain scale. In addition, children with dehydration, and those receiving vasoactive medications were excluded because of the potential alteration in vein size. Protection of Human Subjects Approval of the proposed study was received prior to project implementation from the Institutional Review Board (IRB) at the pediatric hospital serving as the study site. Confidentiality and protection of identifying information for individual subjects occurred by assigning a study identifier number and aggregating data for reporting purposes. Primary investigators involved in the research study completed the National Institutes of Health Office of Extramural Research Protecting Human Research Participants Program prior to initiation of the study. Informed consent was obtained from the parent/legal guardian for all subjects. In addition, assent was sought from subjects aged 10 through 12 years as required by the IRB. Intervention The DeRoyal infant heel warmer is a FDA-approved product, which, when activated and allowed to warm (approximately 45 seconds), maintains a maximum temperature of 104 degrees for ten minutes (DeRoyal product manual, 2006). Some fluctuation of temperature may occur due to ambient temperatures in the area where the product is activated. The researchers followed the manufacturer s guidelines for use to activate the warming mechanism. EMLA Cream is FDA approved to provide dermal and epidermal analgesia from the release of Lidocaine and Prilocaine. It acts directly on the dermal and epidermal pain receptors and nerve endings, promoting analgesia to the affected area (AstraZeneca, 2005). Dosage was directed by physician s order. EMLA Cream was applied to intact skin under an occlusive dressing. Instruments The Wong-Baker FACES Pain Rating Scale is a self-reporting pain level instrument designed to be used with children over the age of 3. The scale is comprised of 6 faces depicting levels of pain resulting in a score from 0 10. The child is asked to point to the face that best reflects his or her pain (Hockenberry, & Wilson, 2007). Reliability, validity, and preference of the FACES Pain Scale is well documented and frequently used in

L. Huff et al. pediatric settings (Keck, Gerkensmeyer, Joyce, & Schade, 1996; Luffy & Grove, 2003; West et al., 1994; Wong & Baker, 1996). The SonoSite iLook 25 was used to measure vein size. The SonoSite iLook 25 is a FDA approved personal imaging vascular ultrasound (SonoSite iLook 25, product manual, 2004). It is used in direct visualization of veins to assist with the insertion of intravenous catheters into vessels which are difficult to visualize. Interrater reliability for vein measurement was established through the examination of six veins by the three research nurses. The intraclass correl ation was strong, at .962, indicating consistency in vein measurement. The investigators created a Vein Visibility Scale which was utilized to assess the difficulty of vein visualization (1 = easily visible, 2 = somewhat visible, and 3 = not visible). Vein visibility was assessed prior to EMLA Cream application, one hour after EMLA Cream , and two minutes after heat application. The participant s age, along with pain score measures, vein measurements, and nursing assessment of vein visibility was recorded on the Procedure Assessment Data Tracking Tool created by the researchers. Participant Enrollment The child-life specialist and unit clinical coordinators contacted the researche rs when a child on the school-age unit required an IV insertion. The researchers determined if the child met inclusion criteria, and the primary care nurse was informed. The researchers provided a study enrollment packet and explained the study to the patient and the patient s legal guardian. The researchers began the enrollment process by obtaining consent for the child to participate in the study. Once consent was obtained from the legal guardian and the child s assent, when appropriate, a study number was assigned to each participant. Venipuncture Protocal Registered nurses who demonstrated competence in performing venipuncture on the school-age child and were identified by their peers as demonstrating excellence in this skill performed the venipuncture procedure. Five registered nurses were selected and educated about the research protocol prior to the initiation of the study to maintain consistency in data collection. The venipuncture procedure was performed according to hospital standards and policy. The researchers implemented the study protocol during the venipuncture procedure. Immediately prior to the initiation of the venipuncture procedure, the researcher obtained a baseline pain score using the Wong-Baker FACES Pain Rating Scale. Next, the RN performing the venipuncture identified the child s vein to be accessed. The researcher, using vascular ultrasound,

Venipuncture in Children directly visualized and measured the vein (measurement #1) and assessed vein visibility using the Vein Visibility Scale, then EMLA Cream was applied to the site for one hour to provide dermal and epidermal analgesia. After removal of the EMLA Cream , the researcher obtained another measurement (#2) of the vein size and visibility. The researcher then applied heat for two minutes using a DeRoyal infant heel warmer, after which the researcher obtained a third measurement (#3) of vein size and visibility. Once the final measure of vein size and visibility was obtained, the RN attempted the venipuncture. After the venipuncture was performed, the researchers, using the Wong-Baker FACES Pain Rating Scale, obtained a second pain score. Data were recorded on the Procedure Assessment Data Tracking Tool by the researcher. DATA ANALYSIS To evaluate the effectiveness of heat on view size and visibility after EMLA Cream , a one way repeated measures ANOVA was used for the two outcome variables. Thirty school-aged children were tested under three conditions: 1) before application of EMLA Cream and heat; 2) after EMLA Cream but before heat was applied; and 3) after both EMLA Cream and heat. A p value < .05 was considered statistically significant. Mauchley s test (W) was performed to assess possible violation of the sphericity assumption; this was not significant for both vein measurement and visualization of the vein (Vein measurement: W = .942, c2 = 1.684, df = 2, p = .431; Vein Visualization: W = .835, c2 = 5.058, df = 2, p = .080). Additionally, Greenhouse Geiser e values of .945 and .858 suggests that both sample variance covariance matrices did not depart substantially from sphericity. Because the Greenhouse Geiser e values were close to 1.00, no correction was made to the degrees of freedom used to evaluate the significance of the F ratio. The Statistical Package for the Social Sciences (SPSS Version 15) for Windows was used for descriptive and multivariate data analysis. All results are reported in aggregate form. RESULTS The study sample included school aged children whose age ranged from 8 to 12 years (mean = 10.0, SD = 1.46), 16 females and 14 males. Vein Measurement Table 1 describes the average vein size over the three time periods. The overall F for differences in average vein measurement across the three times was statistically significant: F(2.58) = 30.4, p = .000; the

L. Huff et al. Table 1. Means and (standard deviations) of vein measurement and visualization (1) Before EMLA (2) After EMLA (3) After EMLA and heat n = 30 before heat n = 30 and heat n = 30 Vein Measurement .243 (.08) .205 (.08) .253 (.07) Vein Visualization 1.37 (.7) 2.33 (.7) 1.67 (.8) Table 2. Post hoc analysis of vein measurement and vein visualization t VM1 to VM1 to VM2 to Visual Visual Visual VM 2 5.28* VM3 -1.58 VM3 -8.16* 1 to Visual 2 -7.37* 2 to Visual 3 -3.07* 1 to Visual 3 6.68*

*p < .05. VM = Vein Measurement. Visual = Vein Visualization. corresponding effect size was a partial h2 = .512, demonstrating that, all other conditions being stable, approximately 51% of the variance in vein measurement could be attributed to the application of EMLA Cream and/or heat. Post hoc analysis revealed a significant difference in vein size between the baseline (VM1) and after application of EMLA Cream (VM2). There was a corresponding difference between vein size after EMLA (VM2) and after application of heat (VM3). There was a statistical difference between the baseline vein size (VM1) and vein measurement after application of EMLA Cream and heat (VM3). See Table 2 for the post hoc t values. Figure 1 illustrates the finding that the average vein measurement of .253 cm after the application of heat was larger when compared to the average vein measurement of .205 cm after EMLA and the baseline measurement of .243 cm. Vein Visualization Table 1 and Figure 2 describe vein visualization over the three time periods. The overall F for differences in average visualization across the three times was statistically significant (F (2.58) = 40.02, p = .000). The corresponding effect size was a partial h2 = .58, denoting that all other conditions being stable, approximately 58% of the variance in visualization can be attributed to

Venipuncture in Children Measurement in cm 0.3 0.26 0.22 Mean Vein Measurement 0.18 0.14 0.1 0.243 0.205 0.253 Measurement Measurement Measurement #1 No Heat or #2 EMLA no #3 EMLA and Emla Heat Heat Figure 1. Vein Measurements before and after EMLA and heat. 3 2.5 1 = Easily visible 2 = Somewhat visible 2 1.37 2.33 1.67 Mean Visualization 3 = Not visible 1.5 1 Measurement Measurement Measurement #1 No Heat or #2 EMLA no #3 EMLA and Emla Heat Heat Figure 2. Vein Visualization rating before and after EMLA and heat. the application of EMLA Cream and/or heat. Post hoc analysis revealed significant differences between all three time periods. See Table 2 for the post hoc t values. Perceptions of Pain Self reported pain levels were measured prior to venipuncture and immediately

after cannula insertion using the Wong-Baker FACES pain scale.

L. Huff et al. There was a significant difference between the pre-procedure level of pain (M = 2.9, SD = 3.0) and post-procedure pain levels (M = 6.9, SD =2.7), t(29) = 6.520, p = .000. LIMITATIONS AND AREAS OF FURTHER STUDY Limitations of the study design and associated areas for future research include: a small, age-limited, convenience sample; and lack of benchmark data on first-attempt IV insertion success rate. As the sample size was limited to 30 children ranging in ages 8 12, future studies including a larger population and age range are indicated. In addition, as the population was limited to Caucasian children, future studies with other racial groups are warranted to explore the impact of skin color on vein visualization. Another limitation was a lack of benchmark data to provide a comparison for the first-attempt success rates for each of the five RNs performing the venipuncture procedure. Past experience and anecdotal reports indicated at least 2 3 attempts were required for successful catheter insertion due to blanching associated with EMLA Cream , but data on first-attempt success rates is not available in the literature and was not acquired prior to the start of the study. This study found a success rate of 80% with the first time attempt of IV insertion with heat after EMLA Cream application, providing a comparison point for future studies. Limitations of the study instrumentation and associated areas for future research include: lack of pre- and post-IV insertion benchmark pain score data and use of the Wong-Baker FACES Pain Rating Scale as the selected measurement for atraumatic care. The study results suggest that anticipatory anxiety with venipuncture may influence the child s report of pain as measured on the Wong-Baker FACES Pain Rating Scale. For example, two different cystic fibrosis patients each verbalized a pain scale of 8 prior to initiating the procedure. So, the question is whether the increase in the post-insertion pain score was due to perceived pain, anticipatory pain, or experiential anxiety from previous venipuncture attempts. Future studies that provide data on pre post-IV insertion pain scores with and without use of EMLA Cream and studies that explore and differentiate the concepts of perceived or anticipatory pain and anxiety would be beneficial. CONCLUSION There have been no prior pediatric and/or adult studies completed that are similar in nature to this study; no other studies have measured venous size or vein visibility in relation to EMLA Cream and heat application. Liu et al. (2003) reviewed heat and EMLA Cream only in relation to length

Venipuncture in Children of onset for anesthesia. Lenhardt et al. (2002) only studied how heat with EMLA Cream facilitated venous cannulation in results to the number of attempts and the time required. The data from this study of school-age children suggest that the application of heat may counteract the adverse effect of vasoconstriction which occurs as a result of EMLA Cream application. The vein measurement results provide evidence of vasoconstriction with the application of EMLA Cream . The baseline mean vein size of .243 cm decreased to a mean vein size of .205 cm after application EMLA Cream . The mean vein size measurement increased beyond the baseline .253 cm after heat was applied. The increase in vein size with heat application corresponds to a reported increase in visibility during IV insertion. There was a significant increase in vein visualization from pre-application of heat to post-application of heat. Therefore, application of heat counteracts the adverse effect of vasoconstriction that occurs with EMLA Cream application, potentially increasing peripheral venous cannulation success rates. Atraumatic care was promoted for these children through successful facilitation of venous cannulation with an 80% first-attempt success rate. In the study hospital, use of heat application after the use of EMLA Cream application to counteract the adverse effect of vasoconstriction has been implemented. REFERENCES Arildsson, M., Asker, C. L., Salerud, E. G., & Stromberg, T. (2000). Skin capill ary appearance and skin microvascular perfusion due to topical application of analge sia cream. [Electronic Version]. Microvascular Research, 59(1), 14 23. Arildsson, M., Nilsson, G. E., & Stromberg, T. (2000). Effects on skin blood flo w by provocation during local analgesia [Electronic Version]. Microvascular Research, 59(1), 122 130. AstraZeneca (2005). EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) [product information]. Wilmington, DE, AstraZeneca LP. Bjerring, B., Anderson PH., & Arendt Nielsen L. (1989).Vascular response of human skin after analgesia with EMLA Cream. British Journal of Anesthesia, 63(6), 655 66 0. DeRoyal (2006). DeRoyal birthing and neonatal products. Retrieved September 22, 2008, from http://www.deroyal.com/literature/documents/0-1347_Neonatal Lit.pdf Haggblad, E., Larsson, M., Arildsson, M., Stromberg, T., & Salerud, E.G. (2001). Reflection spectroscopy of analgesized skin [Electronic Version]. Microvascular Research, 62, 392 400. Hockenberry, M. J., & Wilson, D. (2007). Wong s nursing care of infants and childr en (8th ed). St. Louis: Mosby.

Jimenez N., Bradford H., Seidel KD, Sousa M., & Lynn AM. (2006). A comparison of a needle free injection system for local anesthesia versus EMLA for intravenous cath eter insertion in the pediatric patient. Anesthesia and Analgesia, (2), 411 414.

L. Huff et al. Keck, J. F., Gerkensmeyer, J., Joyce, B., & Schade, J. (1996). Reliability and v alidity of the FACES and word descriptor scales to measure procedural pain. Journal of Pediatri c Nursing, 11, 368 374. Kleiber, C., Gronstal, B.A., Sorenson, M., Whiteside, K., & Tannous, R. (2002). Topical anesthetics for intravenous insertion in children: A randomized equivalency stud y. Pediatrics, 110(4), 758 761. Koh, J. L., Fanurik, D., Stoner, J., Schmitz, M. L., & VonLanthen, M. (1999). Ef ficacy of parental application of eutectic mixture of local anesthetics for intravenous in sertion [Electronic version]. Pediatrics, 103(6). Lenhardt, R., Seybold, T., Kimberger, O., Stoiser, B., & Sessler, D. I. (2002). Local warming and insertion of peripheral venous cannulas: Single blinded prospective randomis ed controlled trial and single blinded randomised crossover trial [Electronic versi on]. British Medical Journal, 325(7361), 409 410. Liu, D. R., Kirchner, H. L., & Petrack, E. M. (2003). Does using heat with eutec tic mixture of local anesthetic cream shorten analgesic onset time?: A randomized, placebo-controlled trial. Annals of Emergency Medicine, 42(1), 27 33. Luffy, R., & Grove, S.K. (2003). Examining the validity, reliability, and prefer ence of three pediatric pain measurement tools in african-american children. Pediatric N ursing, 29, 54 59. Morrison, R. S., Ahronheim, J. G., Morrison, G. R., Darling, E., Baskin, S. A., Morris, J., Choi, C., & Meier, D. (1998). Pain and discomfort associated with common hospita l procedures and experiences. Journal of Pain and Symptom Management, 15(2), 91 101. Rogers, T., & Ostrow, C.L. (2004). The use of EMLA cream to decrease venipunctur e pain in children. Journal of Pediatric Nursing, 19(1), 33 39. SonoSite (2004) Sonosite iLook 25 [product information]. Botheil, WA: SonoSite I nc. Tak J. H., & van Bon W. H. (2006). Pain and distress-reducing interventions for venipuncture in children. Child Care Health Development (3), 257 268. West, N., Oaker, L., Hinds, P. S., Sanders, L., Holder, R., Williams, S., Faircl ough, D., & Bozeman, P. (1994). Measuring pain in pediatric oncology ICU patients. Journal o f

Pediatric Oncology Nursing, 11(2), 64 68.