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The clinical efficacy, interventional ease of use, workload implications, and cost-effectiveness of using needle-free lidocaine for procedural pain management were examined in the pediatric acute care setting. The data from the four studies evaluated indicate that needle-free lidocaine significantly reduces procedural pain and is a cost-effective alternative to the use of topical lidocaine.
Pain management in pediatrics, especially that associated with nonemergent procedures, is an evolving research focus. Venipuncture (VP) and intravenous cannulation (IC) are two common procedures in a pediatric intensive care unit (PICU). A cursory literature search provides ample reports of both procedures as categorically frightening and painful within the pediatric population (Migdal, Chudzynska-Pomianowska, Vause, Henry, & Lazar, 2005; Spanos et al., 2008). Yet, pain management associated with these procedures in the pediatric population has only recently become the focus of many research studies. The intent of this article is to synthesize the findings of four recent studies focused on the topic of VP and IC pain relief following the use of needle-free lidocaine in the pediatric population.
Compliance with care in the pediatric population requires a relationship of trust and security with health care workers. Reducing the pain of the aforementioned procedures (VP and IC) is a key step in developing a healthy rapport and relationship with pediatric patients and their families. Knowing this, PICU nurses have become increasingly more interested in the pain management techniques targeted toward these procedures. Within the past 10 years, there have been many changes in the pain management protocols associated with these pediatric VP and IC. The literature reflects an evolution throughout the past 10 years from the absence of pain relief agents to topical lidocaine-based creams to today's use of needle-free lidocaine. Research studies have afforded clinicians a better understanding of both the efficacy and practicality of pain management strategies that have been utilized with VP and IC procedures. Although many PICUs have since adopted a standing order for the use of needle-free lidocaine prior to IC or VP, many PICU nurses and family members still question the effectiveness of pain management by this technique. Therefore, the intent of this article, to synthesize the findings of four recent studies focused on the topic, is based on answering the clinical question "Is needle-free lidocaine effective in reducing the pain associated with VP and IC in the pediatric population?" (Figure 1).
* P-Pediatric patients (ages 3-18 years).
* I-Needle-free lidocaine delivery (0.25 mg and 0.5 mg).
* C-Placebo and Ela-max treatment.
* O-Pain relief (from VP or IC).
The primary databases used to obtain relevant research studies were EBSCOhost and CINAHL. The literature search was guided by several key words, including needle-free, needle free, lidocaine, pediatrics, pain, and venipuncture. Lidocaine was cross-referenced with both VP and the needle-free terminology. Multiple combinations of the key words were used joined by "and" in the search text boxes. The Cochrane database failed to produce any systematic reviews related to the topic. Most of the articles identified by these key words were related to adult studies or lidocaine-related pain relief associated with other medical conditions. Therefore, the articles were sorted by relevance of key words within the subject of the article. Ten original studies were obtained, and ultimately 4 of the 10 were chosen. One study, in particular, was chosen because, in addition to meeting the criteria for the research focus, it had been performed as a premise to the aforementioned standing order for VP and IC procedural pain management in the local PICU. The search was limited to peer-reviewed sources within the past 5 years.
In the 2008 published study by Zempsky, Robbins, Richards, Leong, and Schechter (2008), the authors reported their findings from an experimentally designed trial including 306 pediatric subjects aged 3-18 years from a single institution. The purpose of the study was to evaluate the effectiveness and comfort of a needle-free lidocaine system (0.5 mg) used for pain reduction with pediatric subjects undergoing VP. The placebo in the trial was the identical delivery system to the needle-free lidocaine. Stringent inclusion and exclusion criteria were used to control bias and risk from confounding or extraneous variables. The subjects from this convenient sample were divided into three age groups (3-7, 8-12, and 13-18 years) and pain score measurement tools appropriate to the age groups were used. The youngest group used a Wong-Baker FACES scale (0-5), the middle group (8-12 years) used both the FACES scale and a Visual Analog Scale (VAS, 100 mm or 0-100), and the oldest group used only the VAS. The mean pain scores reported for the middle-age group using two different scales were analyzed statistically through Glass's meta-analysis.
The results were reported individually by age group as well as combined effect sizes for all ages. Since two scales were used in the middle-age group, the combined effect sizes reflect the use of the mean pain scores by both scales. Individually, the 3- to 7-year group and the 13- to 18-year groups demonstrated statistically significant pain reduction with VP following the use of needle-free lidocaine compared with the placebo treatment. However, the mean pain scores reported by the 8- to 12-year group, while admittedly reduced, failed to achieve statistical significance (p = .073 with FACES, and p = .097 with VAS). The combined treatment effect for all ages demonstrated statistically significant mean pain score reductions (p < .001), using the two analyses with both the FACES and VAS scores from the 8- to 12-year group as mentioned previously. Overall, the findings from this study demonstrate statistically significant effects of the use of needle-free lidocaine in pediatric subjects undergoing VP. Individual age groups had mean pain reductions of 33%-46% with the use of the intervention compared with placebo, and combined ages mean pain scores were reduced 42%-43% compared to placebo. The 8- to 12-year age group had mean pain score reductions of 33%-36% compared to placebo, but, again, these findings failed to achieve statistical significance with either tool (FACES or VAS). The authors of the study allude to "lack of statistical separation in pain ratings" (p. 409) as a potential cause for lower pain scores reported in the 8- to 12-year age control group. Still, they go on to discuss the overall uncertainty of the differences in pain scores with these scales needed to achieve statistical significance. Despite this, the combined ages findings demonstrate significant treatment effects and substantiate findings from other studies of a similar design.
In the randomized, placebo-controlled study by Zempsky, Bean-Lijewski, et al. (2008), the investigators performed a trial with a collective pediatric sample of 579 subjects (aged 3-18 years) from a total of six different institutions within the United States. The purpose of this study was to evaluate the efficacy of needle-free lidocaine (0.5 mg) use for VP pain reduction. The placebo in this trial was also an identical delivery system configuration. As with the study described earlier, the subjects were conveniently obtained. Strict protocol design included stringent inclusion and exclusion criteria. Age blocking was again utilized by the same age criterion (3-7, 8-12, and 13-18 years). The tools used to measure pain scores were the same as the previous study. However, all subjects in this study reported a Wong-Baker FACES score (0-5) and subjects aged 8-18 years also reported a VAS score. Because mean pain scores were reported from three age groups using two different scales (ages 8-18 years), the scores were analyzed using analysis of variance.
Mean pain scores reported using both FACES and VAS demonstrated statistically significant reductions in both age ranges (3-18 FACES, p = .011; and 8-18 VAS, p < .001). A secondary assessment of parental observational pain scores using VAS demonstrated a statistically significant reduction in pain (25%) with VP following the administration of the lidocaine. Strengths specific to this study were the large sample size from varied institutions (broad population sample) and the reported success of first-attempt VP 95.2% for the intervention group and 96.5% for the control group, underscoring the clinical applicability of the use of needle-free lidocaine.
Migdal et al. (2005) conducted a randomized, placebo-controlled experimental study in a single facility to evaluate the optimal dosing configuration of needle-free lidocaine for pain reduction with VP. This study randomly assigned 144 subjects, aged 3-18 years, to three different treatment groups: needle-free placebo, a needle-free lidocaine treatment dose of 0.25 mg, or a needle-free lidocaine treatment dose of 0.5 mg. The subjects were conveniently obtained and were included or excluded on the basis of the criteria similar to those used in the two previously discussed studies. The age criterion (3-7, 8-12, and 13-18 years) used in this study for age blocking was the same as that used in the two aforementioned studies as were the tools used to measure mean pain scores (FACES; FACES and VAS; and VAS, respectively).
The authors report a statistically significant pain reduction in the combined analysis using VAS scores (0.5-mg dose) from the 8- to 12-year age group (p = .039), whereas the combined analysis using FACES scores for the 8- to 12-year age group demonstrated a similar effect size, but failed to reach statistical significance (p = .06). Furthermore, both combined analyses (using FACES vs. VAS scores for the middle-age group) evaluating the 0.25-mg dose of lidocaine failed to achieve statistical significance (VAS scores for middle-age group, p = .064 and p = .115 for the analysis using FACES score for the middle-age group). Overall, the authors report a 47% reduction (pooled effect size) in mean VAS scores, using 0.5-mg lidocaine for 8- to 18-year-old subjects. For the 3- to 12-year age group, a pooled effect size of 31% was reported using mean FACES scores and the 0.5-mg lidocaine dose. The relatively large sample size, experimental design, and strict design protocol using age blocking strengthen the findings in this study. The findings using the 0.5-mg lidocaine dose demonstrated statistical significance across the board using a combined analysis of all ages and VAS scores for the middle-age group, validating a clinical application of the 0.5-mg dose in pediatric practice.
The fourth study reviewed, reported by Spanos et al. (2008), focused on comparing the efficacy of needle-free lidocaine (0.5 mg) with that of topical lidocaine (Ela-max) prior to IC in a single-institution, pediatric emergency department setting. Initially, 861 patients were screened and 781 were excluded on the basis of protocol criteria for subjects. Seven patients or parents declined participation. Seventy conveniently obtained subjects, aged 8-15 years, completed the experimental study. There was no differentiation of age groups as with the three previous studies and only one pain scale (VAS) was used to measure mean pain scores. The subjects were evenly randomized to treatment groups, but the demographic comparison of the groups revealed a much larger percentage of African Americans in the Ela-max group and a larger group of White subjects in both groups overall. Based on this design and sample group, the authors of the study reported statistically significant VP pain reduction compared to the use of Ela-max for pain control. The mean VAS pain score reported for the needle-free lidocaine group was 17.3 (p < .001) and for the Ela-max group was 44.6 (p < .001).
Based on the findings from the individual studies discussed herein, 0.5-mg needle-free lidocaine significantly reduces the pain associated with both VP and IC. The fact that one study (Migdal et al., 2005) focused on both lidocaine efficacy overall and then different lidocaine doses help to validate the use of a standardized dose (of 0.5 mg) within the pediatric population. Furthermore, the study that compared needle-free lidocaine to Ela-max (Spanos et al., 2008), through both efficacy and tolerability parameters, demonstrates the rationale for the evidence-based practice movement to needle-free lidocaine in place of Ela-max in pediatric practice settings.
The ease of use, tolerance, and cost-effectiveness of needle-free lidocaine discussed in the studies, in conjunction with the efficacy findings, further provide a research-based foundation for needle-free lidocaine-based procedural pain management in the pediatric setting. All the studies (Migdal et al., 2005; Spanos et al., 2008; Zempsky, Robbins, et al., 2008; Zempsky, Bean-Lijewski, et al., 2008) reviewed reported that needle-free lidocaine usage was well tolerated among the subjects. Nurses also reported ease-of-use parameters throughout the studies with positive results and successful rates of first attempt VP or IC. Needle-free lidocaine achieves rapid-onset analgesia within 1-3 min whereas the use of Ela-max topical lidocaine can result in delayed onset of analgesia (>30 min). Therefore, with the frequency of VP or IC for nurses in the pediatric setting, this time savings can greatly affect the efficiency of patient care.
Still, Spanos et al. (2008) reported a single-use cost of $2.10 per needle-free lidocaine injector. Charges for a single-patient use (5 g) tube of Ela-Max vary per institution, but generally are in excess of $20 (B. Yarberry, Pharm.D. oral communication, November 2, 2010). Therefore, in addition to the positive pain reduction effects of needle-free lidocaine, it proves to be a nurse-friendly, cost-effective alternative to topical lidocaine.
Randomized clinical trials are considered the gold standard of clinical research. Guyatt and Rennie's (2002) rating system of the strength of evidence places all articles reviewed herein as Level II. Consistent findings through replicated, randomized clinical trials, as were discussed previously, increase the strength and credibility of evidence reported. Therefore, the replication of statistically significant findings found among the four studies provides a strong scientific basis for clinical practice changes for clinicians performing VP or IC procedures in the pediatric setting.
The rigorous protocol design of experimental studies, such as these, through the use of inclusion and exclusion criteria can help control extraneous variables and provide greater confidence in the reported findings. Each of the four articles described previously had similar inclusion and exclusion criteria that helped control bias by excluding subjects with potential confounding variables. Because all of the trials obtained their samples conveniently based on the clinical need for IC or VP throughout different facilities and the samples included inpatients and outpatients as well as patients with both acute and chronic medical needs, the results are not too exclusive of patients of interest. Therefore, the results are more generalizable to the overall pediatric population than if the authors had limited the sample characteristics by inpatient versus outpatient status or children with acute versus chronic medical needs.
Collective strengths of the studies were the use of large samples, with the exception of the modest sample size (70) comparing needle-free lidocaine efficacy with topical lidocaine efficacy (Spanos et al., 2008). Within each study, demographic characteristics were similar except in the study by Spanos et al. (2008). In this study, although the subjects were randomly allocated to treatment groups, the Ela-max group had a larger percentage of African Americans. Although this racial difference is important to identify, it does not appear to have an influence on the findings relative to the findings from studies with more culturally homogeneous groups. Another strength of three of the four studies (Migdal et al., 2005; Zempsky, Robbins, et al., 2008; Zempsky, Bean-Lijewski, et al., 2008) was the use of age blocking, a control measure, and the use of well-established measurement tools based on the defined age ranges and cognitive abilities. The only study that did not differentiate age groups was the study with the smaller sample size and subjects who were aged 8-15 years only (Spanos et al., 2008).
The tools used throughout the studies (Wong-Baker FACES and VAS) are well-known and widely accepted throughout the literature as valid and reliable instruments for assessing pain scores based on the ages that participated in the studies. Therefore, although none of the studies reported internal measures of reliability and validity, the effectiveness of the FACES and VAS tools in measuring the pain score parameters has been well-established in numerous previous studies.
A limitation to randomized clinical trials can be limited clinical applicability due to the rigid research protocol. However, the fact that these studies took "real-world" nursing practice into account was evident by the investigator's choice of VP site or needle gauge (only varied by 1-gauge size in all studies). As a result, clinicians interested in the area of procedural pain management can appreciate the clinical applicability of needle-free lidocaine use with varied injection sites and needle sizes.
As stated earlier, although statistically significant findings overall were reported for combined age groups, pain scores within the 8- to 12-year age range failed to achieve statistical significance in two studies. In the study by Migdal et al. (2005), the 8- to 12-year-old age group findings were significant using the VAS scores, but not significant using FACES scores. Similarly, Zempsky, Robbins, et al. (2008) found treatment effects that were not statistically significant in the 8- to 12-year age group with either scale, FACES or VAS. However, the combined analyses using both scales achieved statistical significance. It is difficult to interpret these differences in any meaningful way. The VAS scale has a larger scale of measure (0-100) versus the FACES (0-5) and perhaps the middle-age group can better assess their pain scores with the longer scale. Despite this difference, the implications of the overall findings outweigh these discrepancies for practice implications.
Based on the robust evidence from four separate research clinical trials, the findings demonstrate credibility, generalizability, and applicability for clinical practice. Integrating the use of needle-free lidocaine into practice prior to IC or VP will be useful in fostering the relationship between pediatric patients, their families, and their nurses. Procedural pain in pediatrics has long been underestimated and undertreated, undermining the trust of pediatric patients. Effective pain management provides security and reflects compassion by nurses. Therefore, it is with confidence that pediatric nurses can and should employ this intervention in the pediatric setting.
Guyatt G., Rennie D. (Eds.). (2002). Users' guide to the medical literature: a manual for evidence-based clinical practice. Chicago, IL: AMA Press. [Context Link]
Migdal M., Chudzynska-Pomianowska E., Vause E., Henry E., Lazar J. (2005). Rapid, needle-free delivery of lidocaine for reducing the pain of venipuncture among pediatric subjects. Pediatrics, 115(4), 393-398. doi:10.1542.peds.2004-065 [Context Link]
Spanos S., Booth R., Koenig H., Sikes K., Gracely E., Kim I. K. (2008). Jet injection of 1% buffered lidocaine versus topical Ela-max for anesthesia before peripheral intravenous catheterization in children. Pediatric Emergency Care, 24(8), 511-515. [Context Link]
Zempsky W. T., Bean-Lijewski J., Kauffman R. E., Koh J. L., Malviya S. V., Rose J. B., et al. (2008). Needle-free powder delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: Randomized, double-blind comparison of venipuncture and venous cannulation pain after fast-onset needle-free powder lidocaine or placebo treatment trial. Pediatrics, 121, 979-987. doi:10.1542/peds.2007-0814 [Context Link]
Zempsky W. T., Robbins B., Richards P. T., Leong M. S., Schechter N. L. (2008). A novel, needle-free powder lidocaine delivery system for rapid local analgesia. The Journal of Pediatrics, 152, 405-411. doi:10.1016/j.jpeds.2007.07.018
For more than 44 additional continuing education articles related to pediatrics. go to http://NursingCenter.com/CE.
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