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The use of EMLA cream to decrease venipuncture pain in children
The Use of EMLA Cream to Decrease Venipuncture Pain in Children Tanya L. Rogers, RN, BSN C. Lynne Ostrow, RN, EdD
Venipuncture is one of the most painful medical procedures for a child, and it is one of the most frequently performed. This literature synthesis reviews evidence for the use of eutectic mixture of local anesthetics (EMLA) cream to reduce the pain children experience during venipuncture. EMLA cream was compared with placebo, iontophoresis, and amethocaine cream and was found to be an effective local anesthetic for pediatric venipuncture pain during both intravenous cannulation and phlebotomy. © 2004 Elsevier Inc. All rights reserved.
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enipuncture is commonly seen as one of the most painful and frequently performed invasive procedures by nurses (Jacobson, 1999). In the pediatric population, venipuncture can be one of the most distressing events associated with medical encounters (Young, Schwartz, & Sheridan, 1996). Many different products, such as eutectic mixture of local anesthetics (EMLA) cream, have been evaluated for their ability to decrease this pain. EMLA cream is an oil–water emulsion of lidocaine and prilocaine, which is applied in a mound over the venipuncture site and covered with a semipermeable dressing, where it is absorbed into the patient’s skin. The mixture is termed eutectic, because the crystalline bases mix to create lower melting points than what would be achieved individually, creating ideal circumstances for skin penetration (Dutta, 1999; Gajraj, Pennant, & Watcha, 1994). Manufacturers recommend an application time of 60 minutes, which allows the anesthetic to hinder initiation and conduction of nerve impulses that cause pain (Choy, Collier, & Watson, 1999; Lander et al., 1996; Hussey, Poulin, & Fain, 1997; May, Britt, & Newman, 1999; Nott & Peacock, 1990). This literature synthesis will review the evidence for use of EMLA cream to reduce the pain children experience during venipuncture and will relate the evidence to implications for nursing practice. Reducing patients’ pain is important for all nurses for many reasons. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Board of Commissioners has revised the standards for assessment and treatment of pain, and institu-
Journal of Pediatric Nursing, Vol 19, No 1 (February), 2004
tions will be held accountable for educating patients about techniques available for pain management (May et al., 1999). Unnecessary pain can erode the nurse–patient relationship (Young et al., 1996), whereas knowledge of alternative techniques can improve patient care and satisfaction (Jacobson, 1999). As advocates for children, nurses are obligated to minimize the emotional and physical effects of painful procedures (Nagengast, 1993). Finally, a less painful venipuncture may lead to less difficulty and higher success rates and, therefore, may spare blood vessel damage, which leaves more sites for later use (Squire, Kirchhoff, & Hissong, 2000).
Review of the Literature EMLA, as an analgesic for venipuncture, has been a popular topic for medical and nursing research since the early 1980s because of great concern regarding pediatric procedural pain. This literature synthesis will shed light on the current studies evaluating EMLA as a local anesthetic for venipuncture, both during blood sampling and intravenous cannulation. Summary tables outlining From School of Nursing, West Virginia University, Morgantown, WV, Fairmont State College, Fairmont, WV, and United Hospital Center, Clarksburg, WV. Address correspondence and reprint requests to Tanya L. Rogers, RN, BSN, 1110 Lake Avenue, Fairmont, WV 26554. E-mail: [email protected] © 2004 Elsevier Inc. All rights reserved. 0882-5963/04/1901-0005$30.00/0 doi:10.1016/j.pedn.2003.09.005 33
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the information from each study are found in Tables 1 and 2. In order to develop a comprehensive literature synthesis, an electronic literature search was conducted to explore the use of EMLA cream to reduce venipuncture pain. Multiple electronic databases, such as CINAHL, EbscoHost, and Medline, were used. The initial search revealed over 50 articles and was narrowed down to the 10 that appear in this literature synthesis. These 10 research articles were chosen because they focused on EMLA cream as the main independent variable and on pain as the main dependent variable. Also, the venipuncture experiences in these studies included both phlebotomy and intravenous cannulation. Sound research designs and thorough descriptions of methods were also essential elements for inclusion. Finally, as the population of interest for this paper was pediatric patients, adult studies were excluded. Young et al. (1996) designed an experimental, randomized, double-blind study to compare the effectiveness of EMLA cream with placebo during venipuncture in 60 subjects between the ages of 6 months and 18 years. Authors measured pain level, anticipatory anxiety, and distress of the child to evaluate the EMLA cream’s effectiveness. Side effects of the EMLA and placebo creams were also noted. According to Gronigan Distress Scale scores, more patients remained calm in the EMLA group (24/30, 80%) versus the placebo group (20/ 29, 69%; p ⫽ 0.02). The parents’ perceived ease of procedure was significantly higher in the EMLA group (p ⫽ 0.003) as was the parents’ report of cream efficacy (p ⫽ 0.0007). Ninety-three percent (28/30) of the parents in the EMLA group reported that the cream was efficient versus 55% (16/29) of the parents in the placebo group. The mean visual analog scale (VAS) scores were significantly less for the EMLA group (M ⫽ 11.7 versus 41.3; p ⫽ 0.0005). The verbal rating scale (VRS) scores rated by the parents were also significantly less for the EMLA group (M ⫽ 0.41 versus 0.68), as well as the VRS scores rated by the child (M ⫽ 0.31 versus 0.60; p ⫽ 0.0001). No difference in anticipatory anxiety was found between the 2 groups. One difference between the groups was that the number of subjects who had experienced venipunctures in the last month was significantly less in the EMLA group than in the placebo group (M ⫽ 0.87 and M ⫽ 1.9, respectively; p ⫽ 0.025). No adverse side effects were reported in either group. Another placebo-controlled study compared EMLA, placebo, and music distraction during in-
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travenous cannulation in 180 children ages 4 to 16. In that study, Arts et al. (1994) also examined the influence of age using an age-stratified design. The principal investigator rated behavioral reactions, and the child rated the pain using a Faces Pain Scale (FPS) and visual analog toy. In this study, mean FPS scores were significantly lower (p ⱕ 0.001) in the EMLA group (M ⫽ 1.42) than the placebo (M ⫽ 2.58) and music distraction groups (M ⫽ 2.62). Younger children (4 to 6) reported significantly more pain than the older children (7 to 11 and 12 to 16), and EMLA exerted its maximal superiority in the youngest age group. Robieux, Kumar, Radhakrishnan, and Koren (1991) sought to determine whether EMLA cream would decrease the pain response safely in infants and toddlers ages 3 months to 36 months of age. This placebo-controlled, randomized, and doubleblind crossover study evaluated the pain response to venipuncture for blood sampling. Pain was measured by a pain scale adapted from Children’s Hospital of Eastern Ontario, heart rate, blood pressure, and VAS. The difficulty of puncture was also assessed using a 4-point scale. The parent, the nurse, and the investigator rated pain on the VAS. The treatment was found to be safe, as measured by methemoglobin levels, which were similar between groups and were within normal limits. Behavioral Pain Scale (BPS) scores increased for both groups after the procedure with significantly smaller changes in the EMLA group than in the placebo group (mean change 1.2, sd ⫽ 1.5 and mean change 1.8, sd ⫽ 1.5, respectively; p ⱕ 0.01), and the mean VAS score was significantly lower with the EMLA cream (M ⫽ 33, sd ⫽ 26) versus the placebo group (M ⫽ 42, sd ⫽ 26; p ⫽ 0.01). Finally, the difficulty of venipuncture was significantly predictive of the VAS scores (r ⫽ 0.3; p ⱕ 0.01); therefore, less difficult venipunctures resulted in lower VAS scores. Wig and Johl (1990) evaluated the ability of EMLA cream versus placebo to reduce pain during intravenous cannulation. The sample consisted of 75 children, 1.5 to 10 years, all premedicated with morphine. In this randomized, blinded, prospective study, authors graded pain using the Manners classification system (1 to 3 scale). Results of the study indicated that pain grading was lower for the EMLA group (p ⱕ 0.005), and 84% of EMLA subjects had no pain compared with only 10% in the placebo group. In another study, Hopkins, Buckley, and Bush (1988) randomly assigned 111 subjects, ages 1 to 5 years, to either EMLA or placebo groups. The
VENIPUNCTURE PAIN IN CHILDREN
35 Table 1. Placebo-controlled studies Purpose
Instruments
Significant Findings
Limitations
Young, Schwartz, & Sheridan (1996)
Study
N ⫽ 60 Ages 6 months-18 yrs Outpatient pediatric office
Sample/Setting
Experimental, Randomized, Placebocontrolled, Doubleblind
Design
Compare the effectiveness of EMLA cream with that of a placebo in reducing stress associated with venipuncture in pediatric outpatients
N ⫽ 180 Age 4–16 Undergoing surgery
Double blind Age-stratified
Robieux, Kumar, Radhakrishnan, & Koren (1991)
N ⫽ 41 Ages 3–36 months in one acute care hospital (32 subjects) & one Outpatient clinic (9 patients)
Experimental, Placebocontrolled, Doubleblind, Crossover, Randomized
Compare the efficacy of a local anesthetic cream and music distraction vs placebo in reducing or preventing pain from intravenous cannulation Examine the influence of age on the pain report, behavior, and therapeutic outcome Determine effect of EMLA on pain response in infants and toddlers as compared to older children and adults Assess the safety of EMLA in the infant and toddler age group
Patients remained more calm in EMLA group (p ⫽ .02) Ease of procedure increased in EMLA group (p ⫽ .003) Parents reported venipunctures in EMLA group to be more efficient Significantly lower VAS & VRS scores in EMLA group Lower self-report and behavioral scores in EMLA as compared with placebo emulsion and with music distraction (p ⬍ .001) Younger children, regardless of intervention, reported more pain than older children (p ⬍ .001) The superiority of the EMLA cream was maximal in the youngest age group BPS scores increased for both groups with smaller changes in EMLA group (p ⬍ .01) Difficulty of puncture was predictive of VAS scores (p ⬍ .01) Lower VAS score with EMLA cream (p ⫽ .01)
Inter-rater variability More venipunctures in last month in placebo group
Arts, Abu-Saad, Champion, Crawford, Fisher, Juniper, Hons, & Ziegler (1994)
Parents efficacy rating Observer’s Anticipatory Anxiety Scale rating Parent’s or child’s VAS and VRS scores Observer’s distress rating (Gronigan Distress Scale, 5point ease of procedure scale, heart rate) Principal investigator behavioral reaction rating Child FPS and visual analogue toy scores
Wig & Johl (1990)
N ⫽ 75 Ages 1 1⁄2–10 elective surgery Pre-medicated with morphine
Randomized, blinded, prospective
Evaluate the efficacy of EMLA Cream in providing a painfree venipuncture in children
Treatment group N ⫽ 50 compared to placebo group N ⫽ 25
Hopkins, Buckley, & Bush (1988)
N ⫽ 111 Ages 1–5 Same-day surgery 24 of EMLA group premedicated vs 14 of placebo group
Randomized, placebocontrolled, doubleblind study
Examine the efficacy of EMLA in alleviation of venipuncture pain at intravenous induction of general anesthesia Identify the optimal application tim Evaluate possible adverse reactions to EMLA
100-mm VAS Operating department assistant VRS with 4 categories and 100-mm VAS
Cooper, Gerrish, Hardwick, & Kay (1987)
N ⫽ 40 Ages 3–13 Routine day case surgery
Double-blind, randomized
Examine EMLA vs placebo on the pain of venipuncture at induction of anesthesia
Patient’s VRS and 10cm VAS scale scores Anesthetist’s rating scale with four categories and 10cm VAS scores Anesthetist’s subjective assessment of procedure difficulty
Lal, McClelland, Phillips, Taub, & Beattie (2001)
N ⫽ 24 Ages 4–8 Outpatient
Prospective, randomized, doubleblind, placebocontrolled study
Evaluate the efficacy of distraction therapy as a coping strategy before and during venipuncture in children and to assess the need for EMLA in these patients
Princess Margaret Hospital Pain Assessment Tool modified to include parent’s assessment. Wong-Baker Faces pain rating scale for self-assessment
Pain grading lower in EMLA group (p ⬍ .005) 84% of EMLA subjects had no pain compared to 10% in placebo group Greater incidence of low pain in subjects treated with EMLA (p ⬍ .001) No significant differences in assessment on arrival between groups, but significant differences within groups with lower scores for premedicated subgroups (p ⬍ .01) Significantly lower scores for patients who received EMLA in both subgroups No correlation between application time and efficacy after an application period of 30 minutes Lower patient VRS scores in EMLA group (p ⬍ .01) Lower observer VRS scores in EMLA group (p ⬍ .01) Lower patient VAS score for EMLA group (p ⬍ .01) Lower doctor’s VAS scores in EMLA group (p ⬍ .01) Venipuncture was easier in the EMLA group (p ⬍ .05) No significant difference in pain scores between the groups
Investigator’s BPS rating adapted from Children’s Hospital of Eastern Ontario Pain Scale Investigator, parent, and nurse’s 10-cm VAS score Heart rate and blood pressure Investigator’s rating of difficulty of puncture on 4-point scale Authors graded pain per Manners classification as grade I, II, or III
VAS, Visual analog scale; VRS, Verbal rating scale; BPS, Behavioral pain scale; FPS, Faces pain scale.
Lack of developmentally appropriate scales for young children
Limitations of BPS scores-in 1⁄4 of cases there was obvious distress before the puncture
Observers reports of pain are often lower than patient self-reports, but authors used same observer to decrease interobserver variation
Lack of developmentally appropriate scales for young children
Pain scores could have been influenced by the sample, skill of the operator, distraction, EMLA, or placebo effect
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ROGERS AND OSTROW Table 2. EMLA vs Iontophoresis or Ametop Sample/Setting
Design
Purpose
Instruments
Significant Findings
Limitations
Galinkin, Rose, Harris, & Watcha (2002)
Study
N ⫽ 26 Ages 7–16 Day Medicine Unit on more than 2 occasions at least 7 days apart
Prospective, randomized, crossover study
Compare the efficacy, side-effect profile, and patient preferences for EMLA vs lidocaine iontophoresis in children undergoing repeated procedures requiring peripheral IV access.
Subject, parent, observer, and technician 100mm VAS scores Observer Children’s Hospital of Eastern Ontario Pain Scale rating Subject satisfaction ratings Likert-type questionnaire regarding “Did you feel an effect from the treatment?” and “Did you like the treatment?”
Cannot generalize to younger age groups
Squire, Kirchhoff, & Hissong (2000)
N ⫽ 100 Ages 5–21 Same-day surgery department Salt Lake City, UT
Experimental Randomly controlled trial
Compare the efficacy of iontophoresis vs EMLA before venipuncture or intravenous cannulation to assess pain levels, amount of time to dermal anesthesia, and success rate of cannulation
Child Faces Pain Scale Parent and investigator VAS Heart rate, blood pressure, oxygen saturation, and temperature
Choy, Collier, & Watson (1999)
N ⫽ 34 Ages 1–14 Nephrology clinic or day case unit
Age-stratified Randomized Singleblinded
Compare the efficacy of EMLA and amethocaine gel when both are used according to the manufacturers’ instructions
Observation Scale of Behavioral Distress Child 10 cm, 100-point VAS with child-friendly graduated colored strip Parent’s rating of child anxiety and distress Doctor rating of child pain and difficulty of insertion
Two subjects could not tolerate iontophoresis No significant differences in pain scores per subject, parent, or observer Parent ratings of the VAS scores were lower than subject ratings (p ⬍ .05) No significant differences among the subjects, parents, observers or technician for intervention preference Child’s FPS scores were lower for iontophoresis group (p ⬍ .001) Parent’s VAS scores were lower for iontophoresis (p ⬍ .01) More erythema, pruritis and tingling in iontophoresis group No significant differences between EMLA and Ametop according to doctor, parent, and child VAS scores or in behavioral distress scores
Broad age range
VAS, Visual analog scale; VRS, Verbal rating scale; BPS, Behavioral pain scale; FPS, Faces pain scale.
child’s behavior on arrival to the operating room was recorded, and the operating department assistant rated the pain during intravenous cannulation using a VRS and VAS score. Some of the children were premedicated (N ⫽ 24), and some were not (N ⫽ 14). Differences were not significant between groups, but within groups, children that were premedicated had lower pain scores (p ⱕ 0.01) on arrival to the operating room. Patients who received EMLA cream had significantly lower scores in both premedicated and non-premedicated subgroups (p ⱕ 0.001). Cooper, Gerrish, Hardwick, and Kay (1987) reported EMLA effectiveness in a double-blind, randomized, placebo-controlled study. Venipuncture in this study was for the purpose of intravenous cannulation. Forty children, ages 3 to 13, participated and rated their own pain using VRS and 10-cm VAS scales. “One patient (aged 4) in the EMLA group and two patients in the placebo group (aged 3 and 5) failed to complete the verbal rating scale, being unable to grasp the concept” (p. 443). The anesthetist rated the child’s pain using 4 categories and the VAS scale and rated the difficulty of the procedure. Both patient and observer
reported lower VAS and VRS scores (p ⬍ .001) in the EMLA group, and the anesthetist also rated venipuncture as less difficult in the EMLA group (p ⬍0.05). In contrast, one placebo-controlled study found no significant difference in pain scores between EMLA and placebo groups (Lal, McClelland, Phillips, Taub, & Beattie, 2001). Children ages 4 to 8 (N ⫽ 24) were randomized into the treatment groups, and all were receiving distraction therapy at the time of venipuncture for blood sampling. The Princess Margaret Hospital Pain Assessment Tool was used and was modified to include parental assessment. The child completed a self-assessment using the Wong-Baker Faces pain rating scale. Pain scores were low in both groups with no significant differences between the groups. The authors did recognize that the low pain scores “may have been due to patient selection, skill of the operator, distraction, EMLA, or ‘placebo effect’ (p. 158).” In addition to placebo, EMLA cream has been compared with other means of anesthesia, such as iontophoresis and other topic anesthetics. Iontophoresis uses an electrical current to administer a
VENIPUNCTURE PAIN IN CHILDREN
topical anesthetic such as lidocaine in the form of ions through intact skin to the dermis. Galinkin, Rose, Harris, and Watcha (2002) compared lidocaine iontophoresis with EMLA in children ages 7 to 16 (N ⫽ 26). In this randomized, crossover study, each patient, scheduled for multiple visits and procedures requiring venipuncture, participated in a total of 3 intravenous cannulations on different days at least 7 days apart. For the first 2 visits, randomization determined the order of treatment (EMLA or iontophoresis), and on the third visit, the patients received their preferred treatment. VAS scores were obtained from the subject and parents, and a blinded observer completed the Children’s Hospital of Eastern Ontario Pain Scale rating. There were no significant differences in the pain scores as assessed by the children; however, parental ratings were significantly lower than patient ratings (p ⬍ 0.05). It is important to note that 2 subjects could not tolerate the iontophoresis, and overall, no significant differences existed in intervention preference. In this study, EMLA cream was found to be comparable with iontophoresis and was preferred in some cases. In another study involving iontophoresis, Squire et al. (2000) compared iontophoresis and EMLA cream in terms of time to accomplish dermal anesthesia and success rate of cannulation. The study included 100 subjects ages 5 to 21 randomized into each group. Dependent variables were pain, as measured by facial pain scale (FPS) by the child and a VAS by the parent and investigator; time to accomplish dermal anesthesia; number of puncture failures; side effects of treatment; and heart rate, blood pressure, oxygen saturation, and temperature. The FPS scores were lower in the iontophoresis group than in the EMLA group (p ⬍ 0.001). The number of minutes required for adequate anesthesia was also less in the iontophoresis group (p ⬍ 0.001), as well as the number of minutes required to acccomplish anesthesia and venipuncture (p ⬍ 0.001). Another significant finding is that more erythema, pruritis, and tingling occurred in the iontophoresis group (p ⬍ 0.0001). Finally, researchers compared EMLA cream with Ametop, another local anesthetic cream consisting of a 4% amethocaine base (Choy et al., 1999). Thirty-four children ages 1 to 14 participated in an age-stratified, randomized, single-blind study to compare the 2 creams. Researchers specifically focused on manufacturers’ instructions, in which 2 g of EMLA cream were applied for 60
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minutes and 1 g of Ametop was applied for 30 to 45 minutes, both under an occlusive dressing. An Observation Scale of Behavioral Distress was used to rate the child’s behavior at three points in time: when the child entered the room, when the child was held still, and during venipuncture. Doctor, parent, and child VAS scores were also collected using a graduated colored strip. Both creams were comparable in their effectiveness, with no significant differences in VAS scores or behavioral distress scores between the groups. This study indicated that EMLA was as effective as Ametop cream, and although Ametop may have certain advantages, such as shorter application time and potential use for children under 1 year of age, it is also more expensive than the EMLA cream. SYNTHESIS According to the results of several studies, EMLA is an effective local anesthetic for pediatric venipuncture pain, either for intravenous cannulation or phlebotomy. When compared with placebo, 6 out of 7 of the studies indicated that EMLA cream was more effective (Young et al., 1996; Arts et al., 1994; Robieux et al., 1991; Wig & Johl, 1990; Hopkins et al., 1988; Cooper et al., 1987). Only one (Lal et al., 2001) found no significant difference between EMLA and placebo; however, there were only 24 subjects included in the study, and they were all receiving distraction therapy in addition to the other treatments. Three studies of IV cannulation compared EMLA with another form of anesthesia, like iontophoresis (Galinkin et al., 2002; Squire et al., 2000) and Ametop cream (Choy et al., 1999). In 1 study, EMLA cream was found to be equally effective as iontophoresis (Galinkin et al., 2002), and in another, iontophoresis resulted in lower pain scores than EMLA cream (Squire et al., 2000). It is important to note that in both of these studies, more side effects were associated with the iontophoresis, and in the study by Galinkin et al. (2002), 2 subjects could not tolerate the iontophoresis treatment long enough to complete anesthesia. EMLA was also found to be comparable with another type of local anesthetic cream, Ametop. EMLA cream is less expensive and more readily available than Ametop (Choy et al., 1999), and for this reason may be more practical to use in children older than 1 year, despite longer recommended application times.
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GAPS AND FUTURE DIRECTIONS Some may claim that EMLA cream is impractical to use because of the application time required for adequate anesthesia (60 minutes). Hopkins et al. (1988) found no correlation between application time and efficacy after an application period of 30 minutes. As this was the only study that evaluated the effectiveness of the EMLA cream in less than 60 minutes, future studies should continue to evaluate shorter application times. Researchers could also address other extraneous variables like difficulty of venipuncture. With a growing population of ill children, a nurse will not always experience an ideal venipuncture situation in which the condition of veins is conducive to success. The effectiveness of EMLA in “difficult stick” situations should be evaluated. As some parents use EMLA cream before their child’s immunizations, studies could evaluate EMLA’s efficacy in reducing pain and fear related to immunizations or injections. The site of insertion should also be considered, for sites may differ in their nerve supply, blood flow, skin thickness, or pathology. Finally, as this cream may be used in the pediatric population, safety should be studied, not only in regard to local side effects or methemoglobin levels, but also in regard to basic child safety issues, such as ingesting the cream, playing with the dressing, or rubbing the cream into the eyes. Also, the cost of a unit of EMLA cream is approximately $6.00 for the pharmacy, which translates into a $10.00 to $40.00 cost for the patient. It would be important to know if, according to the perspective of the patient, the effectiveness of the cream outweighs its cost (Yamamoto & Boychuk, 1998). NURSING IMPLICATIONS When using EMLA cream before venipunctures, there are certain recommendations that nurses may incorporate. As there is a minute chance of the development of higher methemoglobin levels, it is recommended that children less than 1 month old do not receive EMLA cream. Also, 60-minute application times are recommended (Eichenfield, Funk, Fallon-Friedlander, & Cunningham, 2002), until further research can establish the cream’s effectiveness with shorter application times. Lander et al. (1996) determined that application time was a significant factor in the cream’s effectiveness. Although adhering to these application times is sometimes inconvenient, the nurse can anticipate the need for venipuncture and initiate therapy quickly. Northwest Community Hospital
in Arlington Heights, Illinois has adopted an emergency department protocol for EMLA use (EMLA, 2000). In this protocol, anyone appearing at or bypassing triage that may need venipuncture is identified, and EMLA cream is immediately applied. Patients may arrive at clinics earlier for the drug application, or nurses may teach parents how to apply the drug at home (Lander et al., 1996). A solution may lie in merely reorganizing time to allow for application. Finally, even with the use of EMLA cream, pain was still experienced in many of the subjects, so nurses should continue to remember common interventions for relieving pain and comforting a child, regardless of EMLA use. Using EMLA cream could prove to be an asset to nursing care for many reasons and in many different circumstances. In a cost-effective health care society, it is important that nurses seek out ways to provide more efficient care. Difficult venipunctures may require the use of additional personnel and supplies and will require more time of the already busy nurse. “Tough sticks” can be identified, and the use of EMLA cream could increase the ease of procedure (Young et al., 1996; Cooper et al., 1987) and decrease the number of sticks required for successful cannulation. Every pediatric nurse encounters children with “bad veins,” and an anxious patient experiencing unnecessary pain makes the procedure more difficult. Chronically ill children often return to the health care setting frequently and undergo multiple venipunctures. The child’s anxiety could become more intense with each visit, as waning venous access makes venipuncture more difficult. The chronically ill are not the only patients that experience anxiety during venipuncture. Nurses can identify those that are more anxious or have a history of extreme pain and anxiety during the procedure and can appropriately intervene. Patient pain and anxiety, difficult venipunctures, cost effectiveness issues, and time constraints all create anxiety for the nurse. Although venipuncture is a routine task, many nurses become so anxious about “starting IV’s” that they pass the task off to “more experienced” nurses or attempt the venipuncture unsuccessfully, creating a vicious cycle of pain and anxiety for the patient. Above all, nurses should be concerned for the children. Caring is a fundamental concept in nursing, and using EMLA cream is an effective way to alleviate pediatric venipuncture pain, incorporating caring into practice.
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REFERENCES Arts, S., Abu-Saad, H., Champion, G., Crawford, M., Fisher, R., Juniper, K., & Ziegler, J. (1994). Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics, 93, 797-801. Choy, L., Collier, J., & Watson, A. (1999). Comparison of lignocaine-prilocaine cream and amethocaine gel for local analgesia before venepuncture in children. Acta Paediatrics, 88, 961-964. Cooper, C., Gerrish, S., Hardwick, M., & Kay, R. (1987). EMLA cream reduces the pain of venepunture in children. European Journal of Anaesthesiology, 4, 441-448. Dutta, S. (1999). Use of eutectic mixture of local anesthetics in children. Indian Journal of Pediatrics, 66, 707-715. Eichenfield, L., Funk, A., Fallon-Friedlander, S., & Cunningham, B. (2002). A clinical study to evaluate the efficacy of ELA-max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics, 109, 1093-1099. EMLA Cream in the ED protocol. (2000, July). ED Management, 12, insert 1-2. Gajraj, N., Pennant, J., & Watcha, M. (1994). Eutectic mixture of local anesthetics (EMLA) cream. Anesthesia and Analgesia, 78, 574-583. Galinkin, J., Rose, J., Harris, K., & Watcha, M. (2002). Lidocaine iontophoresis versus eutectic mixture of local anesthetics (EMLA) for IV placement in children. Anesthesia & Analgesia, 94, 1484-1488. Hopkins, C., Buckley, C., & Bush, G. (1988). Pain-free injection in infants. Anaesthesia, 43, 198-201. Hussey, V., Poulin, M., & Fain, J. (1997). Effectiveness of lidocaine hydrochloride on venipuncture sites. AORN Journal, 66, 472-480. Jacobson, A. (1999). Intradermal normal saline solution, selfselected music, and insertion difficulty effects on intravenous
insertion pain. Heart and Lung: The Journal of Acute and Critical Care, 28, 114-122. Lal, M., McClelland, J., Phillips, J., Taub, N., & Beattie, R. (2001). Comparison of EMLA cream versus placebo in children receiving distraction therapy for venepuncture. Acta Paediatrics, 90, 154-159. Lander, J., Hodgins, M., Nazarali, J., McTavish, J., Ouellette, J., & Friesen, E. (1996). Determinants of success and failure of EMLA. Pain, 64, 89-97. May, K., Britt, R., & Newman, M. (1999). Pediatric registered nurse usage and perception of EMLA. Journal of the Society of Pediatric Nurses, 4, 105-112. Nagengast, S. (1993). The use of EMLA cream to reduce and/or eliminate procedural pain in children. Journal of Pediatric Nursing, 8, 406-407. Nott, M., & Peacock, J. (1990). Relief of injection pain in adults. EMLA cream for 5 minutes before venepuncture. Anaesthesia, 45, 772-774. Robieux, I., Kumar, R., Radhakrishnan, S., & Koren, G. (1991). Assessing pain and analgesia with a lidocaine-prilocaine emulsion in infants and toddlers during venipuncture. The Journal of Pediatrics, 118, 971-973. Squire, S., Kirchhoff, K., & Hissong, K. (2000). Comparing two methods of topical anesthesia before intravenous cannulation in pediatric patients. Journal of Pediatric Health Care, 14, 68-72. Wig, J., & Johl, K. (1990). Our experience with EMLA cream (for painless venous cannulation in children). Indian Journal of Physiological Pharmacology, 34, 130-132. Yamamoto, L., & Boychuk, R. (1998). A blinded, randomized, paired, placebo-controlled trial of 20-minute EMLA cream to reduce the pain of peripheral IV cannulation in the ED. American Journal of Emergency Medicine, 16, 634-636. Young, S., Schwartz, R., & Sheridan, M. (1996). EMLA cream as a topical anesthetic before office phlebotomy in children. Southern Medical Journal, 89, 1184-1187.
Venipuncture is one of the most painful medical procedures for a child, and it is one of the most frequently performed. This literature synthesis reviews evidence for the use of eutectic mixture of local anesthetics (EMLA) cream to reduce the pain children experience during venipuncture. EMLA cream was compared with placebo, iontophoresis, and amethocaine cream and was found to be an effective local anesthetic for pediatric venipuncture pain during both intravenous cannulation and phlebotomy. © 2004 Elsevier Inc. All rights reserved.
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enipuncture is commonly seen as one of the most painful and frequently performed invasive procedures by nurses (Jacobson, 1999). In the pediatric population, venipuncture can be one of the most distressing events associated with medical encounters (Young, Schwartz, & Sheridan, 1996). Many different products, such as eutectic mixture of local anesthetics (EMLA) cream, have been evaluated for their ability to decrease this pain. EMLA cream is an oil–water emulsion of lidocaine and prilocaine, which is applied in a mound over the venipuncture site and covered with a semipermeable dressing, where it is absorbed into the patient’s skin. The mixture is termed eutectic, because the crystalline bases mix to create lower melting points than what would be achieved individually, creating ideal circumstances for skin penetration (Dutta, 1999; Gajraj, Pennant, & Watcha, 1994). Manufacturers recommend an application time of 60 minutes, which allows the anesthetic to hinder initiation and conduction of nerve impulses that cause pain (Choy, Collier, & Watson, 1999; Lander et al., 1996; Hussey, Poulin, & Fain, 1997; May, Britt, & Newman, 1999; Nott & Peacock, 1990). This literature synthesis will review the evidence for use of EMLA cream to reduce the pain children experience during venipuncture and will relate the evidence to implications for nursing practice. Reducing patients’ pain is important for all nurses for many reasons. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Board of Commissioners has revised the standards for assessment and treatment of pain, and institu-
Journal of Pediatric Nursing, Vol 19, No 1 (February), 2004
tions will be held accountable for educating patients about techniques available for pain management (May et al., 1999). Unnecessary pain can erode the nurse–patient relationship (Young et al., 1996), whereas knowledge of alternative techniques can improve patient care and satisfaction (Jacobson, 1999). As advocates for children, nurses are obligated to minimize the emotional and physical effects of painful procedures (Nagengast, 1993). Finally, a less painful venipuncture may lead to less difficulty and higher success rates and, therefore, may spare blood vessel damage, which leaves more sites for later use (Squire, Kirchhoff, & Hissong, 2000).
Review of the Literature EMLA, as an analgesic for venipuncture, has been a popular topic for medical and nursing research since the early 1980s because of great concern regarding pediatric procedural pain. This literature synthesis will shed light on the current studies evaluating EMLA as a local anesthetic for venipuncture, both during blood sampling and intravenous cannulation. Summary tables outlining From School of Nursing, West Virginia University, Morgantown, WV, Fairmont State College, Fairmont, WV, and United Hospital Center, Clarksburg, WV. Address correspondence and reprint requests to Tanya L. Rogers, RN, BSN, 1110 Lake Avenue, Fairmont, WV 26554. E-mail: [email protected] © 2004 Elsevier Inc. All rights reserved. 0882-5963/04/1901-0005$30.00/0 doi:10.1016/j.pedn.2003.09.005 33
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the information from each study are found in Tables 1 and 2. In order to develop a comprehensive literature synthesis, an electronic literature search was conducted to explore the use of EMLA cream to reduce venipuncture pain. Multiple electronic databases, such as CINAHL, EbscoHost, and Medline, were used. The initial search revealed over 50 articles and was narrowed down to the 10 that appear in this literature synthesis. These 10 research articles were chosen because they focused on EMLA cream as the main independent variable and on pain as the main dependent variable. Also, the venipuncture experiences in these studies included both phlebotomy and intravenous cannulation. Sound research designs and thorough descriptions of methods were also essential elements for inclusion. Finally, as the population of interest for this paper was pediatric patients, adult studies were excluded. Young et al. (1996) designed an experimental, randomized, double-blind study to compare the effectiveness of EMLA cream with placebo during venipuncture in 60 subjects between the ages of 6 months and 18 years. Authors measured pain level, anticipatory anxiety, and distress of the child to evaluate the EMLA cream’s effectiveness. Side effects of the EMLA and placebo creams were also noted. According to Gronigan Distress Scale scores, more patients remained calm in the EMLA group (24/30, 80%) versus the placebo group (20/ 29, 69%; p ⫽ 0.02). The parents’ perceived ease of procedure was significantly higher in the EMLA group (p ⫽ 0.003) as was the parents’ report of cream efficacy (p ⫽ 0.0007). Ninety-three percent (28/30) of the parents in the EMLA group reported that the cream was efficient versus 55% (16/29) of the parents in the placebo group. The mean visual analog scale (VAS) scores were significantly less for the EMLA group (M ⫽ 11.7 versus 41.3; p ⫽ 0.0005). The verbal rating scale (VRS) scores rated by the parents were also significantly less for the EMLA group (M ⫽ 0.41 versus 0.68), as well as the VRS scores rated by the child (M ⫽ 0.31 versus 0.60; p ⫽ 0.0001). No difference in anticipatory anxiety was found between the 2 groups. One difference between the groups was that the number of subjects who had experienced venipunctures in the last month was significantly less in the EMLA group than in the placebo group (M ⫽ 0.87 and M ⫽ 1.9, respectively; p ⫽ 0.025). No adverse side effects were reported in either group. Another placebo-controlled study compared EMLA, placebo, and music distraction during in-
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travenous cannulation in 180 children ages 4 to 16. In that study, Arts et al. (1994) also examined the influence of age using an age-stratified design. The principal investigator rated behavioral reactions, and the child rated the pain using a Faces Pain Scale (FPS) and visual analog toy. In this study, mean FPS scores were significantly lower (p ⱕ 0.001) in the EMLA group (M ⫽ 1.42) than the placebo (M ⫽ 2.58) and music distraction groups (M ⫽ 2.62). Younger children (4 to 6) reported significantly more pain than the older children (7 to 11 and 12 to 16), and EMLA exerted its maximal superiority in the youngest age group. Robieux, Kumar, Radhakrishnan, and Koren (1991) sought to determine whether EMLA cream would decrease the pain response safely in infants and toddlers ages 3 months to 36 months of age. This placebo-controlled, randomized, and doubleblind crossover study evaluated the pain response to venipuncture for blood sampling. Pain was measured by a pain scale adapted from Children’s Hospital of Eastern Ontario, heart rate, blood pressure, and VAS. The difficulty of puncture was also assessed using a 4-point scale. The parent, the nurse, and the investigator rated pain on the VAS. The treatment was found to be safe, as measured by methemoglobin levels, which were similar between groups and were within normal limits. Behavioral Pain Scale (BPS) scores increased for both groups after the procedure with significantly smaller changes in the EMLA group than in the placebo group (mean change 1.2, sd ⫽ 1.5 and mean change 1.8, sd ⫽ 1.5, respectively; p ⱕ 0.01), and the mean VAS score was significantly lower with the EMLA cream (M ⫽ 33, sd ⫽ 26) versus the placebo group (M ⫽ 42, sd ⫽ 26; p ⫽ 0.01). Finally, the difficulty of venipuncture was significantly predictive of the VAS scores (r ⫽ 0.3; p ⱕ 0.01); therefore, less difficult venipunctures resulted in lower VAS scores. Wig and Johl (1990) evaluated the ability of EMLA cream versus placebo to reduce pain during intravenous cannulation. The sample consisted of 75 children, 1.5 to 10 years, all premedicated with morphine. In this randomized, blinded, prospective study, authors graded pain using the Manners classification system (1 to 3 scale). Results of the study indicated that pain grading was lower for the EMLA group (p ⱕ 0.005), and 84% of EMLA subjects had no pain compared with only 10% in the placebo group. In another study, Hopkins, Buckley, and Bush (1988) randomly assigned 111 subjects, ages 1 to 5 years, to either EMLA or placebo groups. The
VENIPUNCTURE PAIN IN CHILDREN
35 Table 1. Placebo-controlled studies Purpose
Instruments
Significant Findings
Limitations
Young, Schwartz, & Sheridan (1996)
Study
N ⫽ 60 Ages 6 months-18 yrs Outpatient pediatric office
Sample/Setting
Experimental, Randomized, Placebocontrolled, Doubleblind
Design
Compare the effectiveness of EMLA cream with that of a placebo in reducing stress associated with venipuncture in pediatric outpatients
N ⫽ 180 Age 4–16 Undergoing surgery
Double blind Age-stratified
Robieux, Kumar, Radhakrishnan, & Koren (1991)
N ⫽ 41 Ages 3–36 months in one acute care hospital (32 subjects) & one Outpatient clinic (9 patients)
Experimental, Placebocontrolled, Doubleblind, Crossover, Randomized
Compare the efficacy of a local anesthetic cream and music distraction vs placebo in reducing or preventing pain from intravenous cannulation Examine the influence of age on the pain report, behavior, and therapeutic outcome Determine effect of EMLA on pain response in infants and toddlers as compared to older children and adults Assess the safety of EMLA in the infant and toddler age group
Patients remained more calm in EMLA group (p ⫽ .02) Ease of procedure increased in EMLA group (p ⫽ .003) Parents reported venipunctures in EMLA group to be more efficient Significantly lower VAS & VRS scores in EMLA group Lower self-report and behavioral scores in EMLA as compared with placebo emulsion and with music distraction (p ⬍ .001) Younger children, regardless of intervention, reported more pain than older children (p ⬍ .001) The superiority of the EMLA cream was maximal in the youngest age group BPS scores increased for both groups with smaller changes in EMLA group (p ⬍ .01) Difficulty of puncture was predictive of VAS scores (p ⬍ .01) Lower VAS score with EMLA cream (p ⫽ .01)
Inter-rater variability More venipunctures in last month in placebo group
Arts, Abu-Saad, Champion, Crawford, Fisher, Juniper, Hons, & Ziegler (1994)
Parents efficacy rating Observer’s Anticipatory Anxiety Scale rating Parent’s or child’s VAS and VRS scores Observer’s distress rating (Gronigan Distress Scale, 5point ease of procedure scale, heart rate) Principal investigator behavioral reaction rating Child FPS and visual analogue toy scores
Wig & Johl (1990)
N ⫽ 75 Ages 1 1⁄2–10 elective surgery Pre-medicated with morphine
Randomized, blinded, prospective
Evaluate the efficacy of EMLA Cream in providing a painfree venipuncture in children
Treatment group N ⫽ 50 compared to placebo group N ⫽ 25
Hopkins, Buckley, & Bush (1988)
N ⫽ 111 Ages 1–5 Same-day surgery 24 of EMLA group premedicated vs 14 of placebo group
Randomized, placebocontrolled, doubleblind study
Examine the efficacy of EMLA in alleviation of venipuncture pain at intravenous induction of general anesthesia Identify the optimal application tim Evaluate possible adverse reactions to EMLA
100-mm VAS Operating department assistant VRS with 4 categories and 100-mm VAS
Cooper, Gerrish, Hardwick, & Kay (1987)
N ⫽ 40 Ages 3–13 Routine day case surgery
Double-blind, randomized
Examine EMLA vs placebo on the pain of venipuncture at induction of anesthesia
Patient’s VRS and 10cm VAS scale scores Anesthetist’s rating scale with four categories and 10cm VAS scores Anesthetist’s subjective assessment of procedure difficulty
Lal, McClelland, Phillips, Taub, & Beattie (2001)
N ⫽ 24 Ages 4–8 Outpatient
Prospective, randomized, doubleblind, placebocontrolled study
Evaluate the efficacy of distraction therapy as a coping strategy before and during venipuncture in children and to assess the need for EMLA in these patients
Princess Margaret Hospital Pain Assessment Tool modified to include parent’s assessment. Wong-Baker Faces pain rating scale for self-assessment
Pain grading lower in EMLA group (p ⬍ .005) 84% of EMLA subjects had no pain compared to 10% in placebo group Greater incidence of low pain in subjects treated with EMLA (p ⬍ .001) No significant differences in assessment on arrival between groups, but significant differences within groups with lower scores for premedicated subgroups (p ⬍ .01) Significantly lower scores for patients who received EMLA in both subgroups No correlation between application time and efficacy after an application period of 30 minutes Lower patient VRS scores in EMLA group (p ⬍ .01) Lower observer VRS scores in EMLA group (p ⬍ .01) Lower patient VAS score for EMLA group (p ⬍ .01) Lower doctor’s VAS scores in EMLA group (p ⬍ .01) Venipuncture was easier in the EMLA group (p ⬍ .05) No significant difference in pain scores between the groups
Investigator’s BPS rating adapted from Children’s Hospital of Eastern Ontario Pain Scale Investigator, parent, and nurse’s 10-cm VAS score Heart rate and blood pressure Investigator’s rating of difficulty of puncture on 4-point scale Authors graded pain per Manners classification as grade I, II, or III
VAS, Visual analog scale; VRS, Verbal rating scale; BPS, Behavioral pain scale; FPS, Faces pain scale.
Lack of developmentally appropriate scales for young children
Limitations of BPS scores-in 1⁄4 of cases there was obvious distress before the puncture
Observers reports of pain are often lower than patient self-reports, but authors used same observer to decrease interobserver variation
Lack of developmentally appropriate scales for young children
Pain scores could have been influenced by the sample, skill of the operator, distraction, EMLA, or placebo effect
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ROGERS AND OSTROW Table 2. EMLA vs Iontophoresis or Ametop Sample/Setting
Design
Purpose
Instruments
Significant Findings
Limitations
Galinkin, Rose, Harris, & Watcha (2002)
Study
N ⫽ 26 Ages 7–16 Day Medicine Unit on more than 2 occasions at least 7 days apart
Prospective, randomized, crossover study
Compare the efficacy, side-effect profile, and patient preferences for EMLA vs lidocaine iontophoresis in children undergoing repeated procedures requiring peripheral IV access.
Subject, parent, observer, and technician 100mm VAS scores Observer Children’s Hospital of Eastern Ontario Pain Scale rating Subject satisfaction ratings Likert-type questionnaire regarding “Did you feel an effect from the treatment?” and “Did you like the treatment?”
Cannot generalize to younger age groups
Squire, Kirchhoff, & Hissong (2000)
N ⫽ 100 Ages 5–21 Same-day surgery department Salt Lake City, UT
Experimental Randomly controlled trial
Compare the efficacy of iontophoresis vs EMLA before venipuncture or intravenous cannulation to assess pain levels, amount of time to dermal anesthesia, and success rate of cannulation
Child Faces Pain Scale Parent and investigator VAS Heart rate, blood pressure, oxygen saturation, and temperature
Choy, Collier, & Watson (1999)
N ⫽ 34 Ages 1–14 Nephrology clinic or day case unit
Age-stratified Randomized Singleblinded
Compare the efficacy of EMLA and amethocaine gel when both are used according to the manufacturers’ instructions
Observation Scale of Behavioral Distress Child 10 cm, 100-point VAS with child-friendly graduated colored strip Parent’s rating of child anxiety and distress Doctor rating of child pain and difficulty of insertion
Two subjects could not tolerate iontophoresis No significant differences in pain scores per subject, parent, or observer Parent ratings of the VAS scores were lower than subject ratings (p ⬍ .05) No significant differences among the subjects, parents, observers or technician for intervention preference Child’s FPS scores were lower for iontophoresis group (p ⬍ .001) Parent’s VAS scores were lower for iontophoresis (p ⬍ .01) More erythema, pruritis and tingling in iontophoresis group No significant differences between EMLA and Ametop according to doctor, parent, and child VAS scores or in behavioral distress scores
Broad age range
VAS, Visual analog scale; VRS, Verbal rating scale; BPS, Behavioral pain scale; FPS, Faces pain scale.
child’s behavior on arrival to the operating room was recorded, and the operating department assistant rated the pain during intravenous cannulation using a VRS and VAS score. Some of the children were premedicated (N ⫽ 24), and some were not (N ⫽ 14). Differences were not significant between groups, but within groups, children that were premedicated had lower pain scores (p ⱕ 0.01) on arrival to the operating room. Patients who received EMLA cream had significantly lower scores in both premedicated and non-premedicated subgroups (p ⱕ 0.001). Cooper, Gerrish, Hardwick, and Kay (1987) reported EMLA effectiveness in a double-blind, randomized, placebo-controlled study. Venipuncture in this study was for the purpose of intravenous cannulation. Forty children, ages 3 to 13, participated and rated their own pain using VRS and 10-cm VAS scales. “One patient (aged 4) in the EMLA group and two patients in the placebo group (aged 3 and 5) failed to complete the verbal rating scale, being unable to grasp the concept” (p. 443). The anesthetist rated the child’s pain using 4 categories and the VAS scale and rated the difficulty of the procedure. Both patient and observer
reported lower VAS and VRS scores (p ⬍ .001) in the EMLA group, and the anesthetist also rated venipuncture as less difficult in the EMLA group (p ⬍0.05). In contrast, one placebo-controlled study found no significant difference in pain scores between EMLA and placebo groups (Lal, McClelland, Phillips, Taub, & Beattie, 2001). Children ages 4 to 8 (N ⫽ 24) were randomized into the treatment groups, and all were receiving distraction therapy at the time of venipuncture for blood sampling. The Princess Margaret Hospital Pain Assessment Tool was used and was modified to include parental assessment. The child completed a self-assessment using the Wong-Baker Faces pain rating scale. Pain scores were low in both groups with no significant differences between the groups. The authors did recognize that the low pain scores “may have been due to patient selection, skill of the operator, distraction, EMLA, or ‘placebo effect’ (p. 158).” In addition to placebo, EMLA cream has been compared with other means of anesthesia, such as iontophoresis and other topic anesthetics. Iontophoresis uses an electrical current to administer a
VENIPUNCTURE PAIN IN CHILDREN
topical anesthetic such as lidocaine in the form of ions through intact skin to the dermis. Galinkin, Rose, Harris, and Watcha (2002) compared lidocaine iontophoresis with EMLA in children ages 7 to 16 (N ⫽ 26). In this randomized, crossover study, each patient, scheduled for multiple visits and procedures requiring venipuncture, participated in a total of 3 intravenous cannulations on different days at least 7 days apart. For the first 2 visits, randomization determined the order of treatment (EMLA or iontophoresis), and on the third visit, the patients received their preferred treatment. VAS scores were obtained from the subject and parents, and a blinded observer completed the Children’s Hospital of Eastern Ontario Pain Scale rating. There were no significant differences in the pain scores as assessed by the children; however, parental ratings were significantly lower than patient ratings (p ⬍ 0.05). It is important to note that 2 subjects could not tolerate the iontophoresis, and overall, no significant differences existed in intervention preference. In this study, EMLA cream was found to be comparable with iontophoresis and was preferred in some cases. In another study involving iontophoresis, Squire et al. (2000) compared iontophoresis and EMLA cream in terms of time to accomplish dermal anesthesia and success rate of cannulation. The study included 100 subjects ages 5 to 21 randomized into each group. Dependent variables were pain, as measured by facial pain scale (FPS) by the child and a VAS by the parent and investigator; time to accomplish dermal anesthesia; number of puncture failures; side effects of treatment; and heart rate, blood pressure, oxygen saturation, and temperature. The FPS scores were lower in the iontophoresis group than in the EMLA group (p ⬍ 0.001). The number of minutes required for adequate anesthesia was also less in the iontophoresis group (p ⬍ 0.001), as well as the number of minutes required to acccomplish anesthesia and venipuncture (p ⬍ 0.001). Another significant finding is that more erythema, pruritis, and tingling occurred in the iontophoresis group (p ⬍ 0.0001). Finally, researchers compared EMLA cream with Ametop, another local anesthetic cream consisting of a 4% amethocaine base (Choy et al., 1999). Thirty-four children ages 1 to 14 participated in an age-stratified, randomized, single-blind study to compare the 2 creams. Researchers specifically focused on manufacturers’ instructions, in which 2 g of EMLA cream were applied for 60
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minutes and 1 g of Ametop was applied for 30 to 45 minutes, both under an occlusive dressing. An Observation Scale of Behavioral Distress was used to rate the child’s behavior at three points in time: when the child entered the room, when the child was held still, and during venipuncture. Doctor, parent, and child VAS scores were also collected using a graduated colored strip. Both creams were comparable in their effectiveness, with no significant differences in VAS scores or behavioral distress scores between the groups. This study indicated that EMLA was as effective as Ametop cream, and although Ametop may have certain advantages, such as shorter application time and potential use for children under 1 year of age, it is also more expensive than the EMLA cream. SYNTHESIS According to the results of several studies, EMLA is an effective local anesthetic for pediatric venipuncture pain, either for intravenous cannulation or phlebotomy. When compared with placebo, 6 out of 7 of the studies indicated that EMLA cream was more effective (Young et al., 1996; Arts et al., 1994; Robieux et al., 1991; Wig & Johl, 1990; Hopkins et al., 1988; Cooper et al., 1987). Only one (Lal et al., 2001) found no significant difference between EMLA and placebo; however, there were only 24 subjects included in the study, and they were all receiving distraction therapy in addition to the other treatments. Three studies of IV cannulation compared EMLA with another form of anesthesia, like iontophoresis (Galinkin et al., 2002; Squire et al., 2000) and Ametop cream (Choy et al., 1999). In 1 study, EMLA cream was found to be equally effective as iontophoresis (Galinkin et al., 2002), and in another, iontophoresis resulted in lower pain scores than EMLA cream (Squire et al., 2000). It is important to note that in both of these studies, more side effects were associated with the iontophoresis, and in the study by Galinkin et al. (2002), 2 subjects could not tolerate the iontophoresis treatment long enough to complete anesthesia. EMLA was also found to be comparable with another type of local anesthetic cream, Ametop. EMLA cream is less expensive and more readily available than Ametop (Choy et al., 1999), and for this reason may be more practical to use in children older than 1 year, despite longer recommended application times.
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GAPS AND FUTURE DIRECTIONS Some may claim that EMLA cream is impractical to use because of the application time required for adequate anesthesia (60 minutes). Hopkins et al. (1988) found no correlation between application time and efficacy after an application period of 30 minutes. As this was the only study that evaluated the effectiveness of the EMLA cream in less than 60 minutes, future studies should continue to evaluate shorter application times. Researchers could also address other extraneous variables like difficulty of venipuncture. With a growing population of ill children, a nurse will not always experience an ideal venipuncture situation in which the condition of veins is conducive to success. The effectiveness of EMLA in “difficult stick” situations should be evaluated. As some parents use EMLA cream before their child’s immunizations, studies could evaluate EMLA’s efficacy in reducing pain and fear related to immunizations or injections. The site of insertion should also be considered, for sites may differ in their nerve supply, blood flow, skin thickness, or pathology. Finally, as this cream may be used in the pediatric population, safety should be studied, not only in regard to local side effects or methemoglobin levels, but also in regard to basic child safety issues, such as ingesting the cream, playing with the dressing, or rubbing the cream into the eyes. Also, the cost of a unit of EMLA cream is approximately $6.00 for the pharmacy, which translates into a $10.00 to $40.00 cost for the patient. It would be important to know if, according to the perspective of the patient, the effectiveness of the cream outweighs its cost (Yamamoto & Boychuk, 1998). NURSING IMPLICATIONS When using EMLA cream before venipunctures, there are certain recommendations that nurses may incorporate. As there is a minute chance of the development of higher methemoglobin levels, it is recommended that children less than 1 month old do not receive EMLA cream. Also, 60-minute application times are recommended (Eichenfield, Funk, Fallon-Friedlander, & Cunningham, 2002), until further research can establish the cream’s effectiveness with shorter application times. Lander et al. (1996) determined that application time was a significant factor in the cream’s effectiveness. Although adhering to these application times is sometimes inconvenient, the nurse can anticipate the need for venipuncture and initiate therapy quickly. Northwest Community Hospital
in Arlington Heights, Illinois has adopted an emergency department protocol for EMLA use (EMLA, 2000). In this protocol, anyone appearing at or bypassing triage that may need venipuncture is identified, and EMLA cream is immediately applied. Patients may arrive at clinics earlier for the drug application, or nurses may teach parents how to apply the drug at home (Lander et al., 1996). A solution may lie in merely reorganizing time to allow for application. Finally, even with the use of EMLA cream, pain was still experienced in many of the subjects, so nurses should continue to remember common interventions for relieving pain and comforting a child, regardless of EMLA use. Using EMLA cream could prove to be an asset to nursing care for many reasons and in many different circumstances. In a cost-effective health care society, it is important that nurses seek out ways to provide more efficient care. Difficult venipunctures may require the use of additional personnel and supplies and will require more time of the already busy nurse. “Tough sticks” can be identified, and the use of EMLA cream could increase the ease of procedure (Young et al., 1996; Cooper et al., 1987) and decrease the number of sticks required for successful cannulation. Every pediatric nurse encounters children with “bad veins,” and an anxious patient experiencing unnecessary pain makes the procedure more difficult. Chronically ill children often return to the health care setting frequently and undergo multiple venipunctures. The child’s anxiety could become more intense with each visit, as waning venous access makes venipuncture more difficult. The chronically ill are not the only patients that experience anxiety during venipuncture. Nurses can identify those that are more anxious or have a history of extreme pain and anxiety during the procedure and can appropriately intervene. Patient pain and anxiety, difficult venipunctures, cost effectiveness issues, and time constraints all create anxiety for the nurse. Although venipuncture is a routine task, many nurses become so anxious about “starting IV’s” that they pass the task off to “more experienced” nurses or attempt the venipuncture unsuccessfully, creating a vicious cycle of pain and anxiety for the patient. Above all, nurses should be concerned for the children. Caring is a fundamental concept in nursing, and using EMLA cream is an effective way to alleviate pediatric venipuncture pain, incorporating caring into practice.
VENIPUNCTURE PAIN IN CHILDREN
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insertion pain. Heart and Lung: The Journal of Acute and Critical Care, 28, 114-122. Lal, M., McClelland, J., Phillips, J., Taub, N., & Beattie, R. (2001). Comparison of EMLA cream versus placebo in children receiving distraction therapy for venepuncture. Acta Paediatrics, 90, 154-159. Lander, J., Hodgins, M., Nazarali, J., McTavish, J., Ouellette, J., & Friesen, E. (1996). Determinants of success and failure of EMLA. Pain, 64, 89-97. May, K., Britt, R., & Newman, M. (1999). Pediatric registered nurse usage and perception of EMLA. Journal of the Society of Pediatric Nurses, 4, 105-112. Nagengast, S. (1993). The use of EMLA cream to reduce and/or eliminate procedural pain in children. Journal of Pediatric Nursing, 8, 406-407. Nott, M., & Peacock, J. (1990). Relief of injection pain in adults. EMLA cream for 5 minutes before venepuncture. Anaesthesia, 45, 772-774. Robieux, I., Kumar, R., Radhakrishnan, S., & Koren, G. (1991). Assessing pain and analgesia with a lidocaine-prilocaine emulsion in infants and toddlers during venipuncture. The Journal of Pediatrics, 118, 971-973. Squire, S., Kirchhoff, K., & Hissong, K. (2000). Comparing two methods of topical anesthesia before intravenous cannulation in pediatric patients. Journal of Pediatric Health Care, 14, 68-72. Wig, J., & Johl, K. (1990). Our experience with EMLA cream (for painless venous cannulation in children). Indian Journal of Physiological Pharmacology, 34, 130-132. Yamamoto, L., & Boychuk, R. (1998). A blinded, randomized, paired, placebo-controlled trial of 20-minute EMLA cream to reduce the pain of peripheral IV cannulation in the ED. American Journal of Emergency Medicine, 16, 634-636. Young, S., Schwartz, R., & Sheridan, M. (1996). EMLA cream as a topical anesthetic before office phlebotomy in children. Southern Medical Journal, 89, 1184-1187.