Anesth Analg 2006;102:411-414
© 2006 International Anesthesia Research Society
doi: 10.1213/01.ane.0000194293.10549.62
PEDIATRIC ANESTHESIA
A Comparison of a Needle-Free Injection System for Local Anesthesia Versus EMLA® for Intravenous Catheter Insertion in the Pediatric Patient
Nathalia Jimenez, MD,
Heidi Bradford, BA,
Kristy D. Seidel, MS,
Manuela Sousa, MD, and
Anne M. Lynn, MD
Department of Anesthesiology and Pain Medicine, Children's Hospital and Regional Medical Center, University of Washington School of Medicine, Seattle
Address correspondence and reprint requests to Nathalia Jimenez, MD, Children's Hospital and Regional Medical Center, 4800 Sand Point Way NE, Seattle, WA 98105. Address e-mail to nathalia.jimenez{at}seattlechildrens.org.
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Abstract
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Placement of IV catheters is a painful and stressful procedure for children. J-Tip® is a needle-less Food and Drug Administration approved injection system that can be used for delivery of local anesthetic before IV cannulation. In this study, we compared the effectiveness of J-Tip® versus eutectic mixture of local anesthetics (EMLA®) to facilitate IV cannulation and provide adequate analgesia before IV placement. Children 7–19 years of age (n = 116) were randomized to receive 0.25 mL of 1% buffered lidocaine with J-Tip® (n = 57) or 2.5 g of EMLA® (n = 59) before IV cannulation. Measurements of success of cannulation (number of attempts for IV placement) and pain (0–10 visual analog scale) at application of local anesthetic and at cannulation were performed. There was a significant (P = 0.0001) difference in pain ratings during IV cannulation between EMLA® (median = 3) and the J-Tip® (median = 0). Eighty-four percent of patients reported no pain at the time of J-Tip® lidocaine application compared to 61% in the EMLA® group at the time of dressing removal (P = 0.004). We did not find differences in the number of attempts for IV cannulation. J-Tip® application of 1% buffered lidocaine before IV cannulation is not painful and has better anesthetic effectiveness compared with EMLA®.
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Introduction
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Placement of IV catheters is a painful and stressful procedure for children. Pain-free IV catheter placement has been reported after the application of local anesthesia before cannulation. Topical local anesthetic preparations, such as eutectic mixture of local anesthetics (EMLA®; AstraZeneca Pharmaceuticals LP, Wilmington, Delaware), have become the standard of care in many pediatric institutions. However, its effectiveness is limited by the fact that optimal analgesia requires application 60–90 min before IV placement (1). Vasoconstriction may also occur, leading to difficult IV cannulation in 40%–50% of patients (2,3). Studies have shown clinical evidence of vasoconstriction measured by blanching appearance with EMLA® use in up to 83% (1) of patients, confirming early results that report maximum vasoconstriction measured by laser Doppler flowmetry at 90 min (4), the time at which the best analgesia is achieved (1,4).
J-Tip® (National Medical Products Inc, Irvine, California) is a new needle-less Food and Drug Administration approved injection system that can be used for delivery of local anesthesia. It is a sterile, single-use, needle-less syringe that delivers the medication under high pressure from a compressed carbon dioxide gas cartridge (Fig. 1). The cartridge drives the plunger down the barrel of the syringe, expelling the medication through a micro-orifice. The medication under pressure penetrates the skin surface and subcutaneous tissues to a depth of 5–8 mm in 0.2 s. The lack of needle involvement, quick onset of action, and absence of vasoconstriction make it an attractive option for local anesthetic delivery before IV placement in the pediatric population. This study compares the effectiveness of J-Tip® versus EMLA® to facilitate IV cannulation and provide adequate analgesia before IV placement in children.
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Methods
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This study was approved by the IRB of Children's Hospital and Regional Medical Center in Seattle, Washington. Written consent was obtained from the parents or legal guardians, and assent was obtained from children 8 yr and older. Children 7–19 yr old who required IV placement before elective surgery were eligible for the study. Exclusion criteria included known allergic reaction to lidocaine or prilocaine, diagnosis of methemoglobinemia, treatment with sulfa medications, preoperative analgesic treatment (except for nonsteroidal antiinflammatory drugs and acetaminophen), sensory deficits in upper extremities, and intellectual disabilities that prevented completion of a visual analog scale (VAS).
Using simple randomization, with a computer random number generator and sealed envelopes, patients were assigned to receive either 2.5 g of EMLA® on the dorsum of both hands or 0.25 mL of 1% buffered lidocaine injected with J-Tip® for local anesthetic before IV placement. It was expected that time from study consent to IV cannulation would exceed 60 min, allowing optimal analgesia in the EMLA® group. IV cannulation was performed by experienced nursing or anesthesia personnel. For the EMLA® treatment group, the two possible sites for venipuncture were covered by a thick layer of cream and an occlusive dressing (Tegaderm®; 3M, St. Paul, Minnesota). At the time of IV placement, the cream was removed and cannulation performed. For the patients in the J-Tip® group, a set of three J-Tip® injectors was available: two J-Tips® for injection of local anesthesia at each of two possible sites and a third for patient demonstration. A characteristic of the J-Tip® is that it makes a noticeable pop sound when the CO2 cartridge is activated. If the person doing the cannulation anticipated that the child could be frightened by the noise produced by the J-Tip®, they had the ability to show how the J-Tip® worked before actually using it to deliver subcutaneous local anesthetic.
Patients were asked to rate their pain at the time of removal of the Tegaderm® dressing in the EMLA® group and at the time of lidocaine application in the J-Tip® group. Both groups were asked also to rate their pain at the time of cannulation. If more than two attempts were required for cannulation, only pain scores from the first two attempts were used in the analysis. All pain ratings were performed using a VAS from 0–10, with 0 being no pain and 10 the most intense possible pain. Time from application to cannulation for both groups was recorded. To assess difficulty of cannulation, two measurements were performed. The anesthesiologist or nurse performing the cannulation reported the number of attempts for cannulation and ease of the procedure using a dichotomous scale (easy or difficult).
A sample size of 200 patients was calculated based on a projected difference of 20% in success of cannulation between the two groups and a power (1-ß) of 0.8 at the 0.05 level of significance (
). Statistical methods for comparing the J-Tip® group versus the EMLA® group included Wilcoxon's ranked sum test for ordinal and continuous scale variables and 
2 testing for categorical variables. An interim analysis was conducted when accrual reached 116 subjects, and the trial was halted at that point. Consequently, adjusted significance cutoffs are used to assure that the overall Type I error rate () does not exceed 0.05. The basis of all adjustment techniques for conducting interim analysis in clinical trials is the requirement of a smaller (more stringent) significance cutoff at the interim analysis time point than the one required if the trial were to proceed to full accrual. A variety of functions have been proposed for parsing out a trial's across sequential analyses in such a way that the overall Type I error probability cumulates to the desired 0.05. We chose the fairly conservative approach of Lan and DeMets. The Lan and DeMets error-spending approach (5), with the power-family spending function and 
set to 3, has properties similar to the better known O'Brien-Fleming stopping boundaries, but it is easier to apply in situations where the sequential analyses may not be exactly equally spaced across the trial. Using this approach, the adjusted significance cutoff to be applied at the interim analysis was calculated to be 0.005. Because the trial was terminated early, there was only a statistical significant difference when the P value <0.005.
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Results
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We recruited 116 patients of the 200 initially projected. An interim analysis showed frequent and similar success rates for initial cannulation attempt in the two groups, a result that seemed unlikely to change with the additional 84 patients planned. The conditional power of the study at full accrual, given the data available at the halfway point, was computed. This revealed a less than 10% chance that continuing to full accrual would yield a statistically significant result for the comparison of initial cannulation success rates, assuming that the current estimates of the success rates in each group are true. An additional factor in choosing to curtail accrual early was that the secondary study end-points (VAS pain scores) already showed strongly significant differences between the EMLA® and J-Tip® groups.
Of the 116 patients, 59 patients were in the EMLA® group, and 57 were in the J-Tip® group. Groups were similar in age and sex distribution. (Table 1). The median age was 13 and 14 yr for the J-Tip® and EMLA® groups, respectively. Only one patient in each group received midazolam; the rest of the patients did not receive premedication. For the EMLA® group, the mean time from application to IV cannulation was 69 min (sd 32) and 1.8 min (sd 0.7) for the J-Tip® Group (Table 2).
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Table 2. Time from Application to IV Cannulation, Number of Attempts, and Ease of Cannulation for J-Tip® and Eutectic Mixture of Local Anesthetics (EMLA®) Groups
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There was a significant difference (P = 0.0001) in pain ratings during IV cannulation between the EMLA® group (median, 3) and J-Tip® group (median, 0). Because 40% of the patients in the EMLA® group had application times less than the recommended 60 min, we conducted a subset analysis comparing J-Tip® subjects with only those EMLA® subjects who had application times 
60 min. The comparison between J-Tip® and EMLA® remained significant in this restricted subtest analysis (P = 0.0013). The VAS pain scores reported at the time of application of buffered lidocaine with the J-Tip® were also significantly lower than pain scores reported at the time of dressing removal in the EMLA® group (P = 0.004; Fig. 2). The percentage of patients reporting no pain at application of the J-Tip® was 84% compared to 61% in the EMLA® group at the time of dressing removal. Both of the comparisons involving VAS pain scores meet the more stringent significance cutoff of P < 0.005, required by the interim analysis and early termination of accrual.
With regard to the difficulty of the procedure, 89% of the cannulations were reported as easy in the J-Tip® group compared to 72% in the EMLA® group (P = 0.022). This comparison does not meet the stringent <0.005 criterion for statistical significance. The distribution of the number of attempts required for successful cannulation is shown for each group in Table 2.
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Discussion
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Our study found similar outcomes in both groups with regard to the study's primary outcome measure of success on first cannulation attempt. However, information gathered on the secondary outcome of self-reported pain score during cannulation clearly demonstrates that J-Tip® application of buffered 1% lidocaine one to three minutes before IV cannulation has better anesthetic effectiveness than EMLA® cream applied an average of 69 minutes before IV cannulation. It also demonstrates that J-Tip® delivery of buffered lidocaine was not painful and was well tolerated by pediatric patients. The distribution of the number of attempts required for IV cannulation was similar in both groups.
Our finding of no pain at the time of IV cannulation is consistent with a previous report in the adult population (6). Although we had hypothesized the possibility of a negative effect on pain ratings at the time of application by the noise produced by the J-Tip®, we did not observe such an effect. This finding could be explained by the familiarity the patient developed with the device before its use. The difference in pain ratings at the time of cannulation, when compared with reports of studies performed on adults, may be explained by the fact that pediatric patients have a thicker subcutaneous tissue, allowing a deeper penetration of local anesthetic and therefore better analgesia (6,7).
The finding of no difference between groups in success of cannulation was not predicted. It may be explained by the fact that the personnel performing the cannulation in our care setting are highly trained in pediatrics. That J-Tip®'s lack of vasoconstriction was helpful and was emphasized by the fact that although there was no difference in the number of attempts for cannulation, the providers rated the difficulty of the procedure for the two groups somewhat differently.
One of the limitations of our study is that a proportion of patients in the EMLA® group had times after application <60 minutes. Our expectation was to have all patients with EMLA® in place for this time as a minimum, although changes in the surgical schedule did not always allow us to do so. The separate analysis that we conducted considering only patients with EMLA® times more than 60 minutes did not show any differences when compared with the analysis performed with the whole group. This fact supports our final results and simply represents the real-life challenges presented by the use of EMLA® in a busy surgical setting.
Another limitation is that we studied primarily a preteen and adolescent group. One study using the J-Tip® in children younger than seven years of age has shown that children in this age group seem to be more disturbed by the noise produced by the J-Tip® cartridge, although the resistance to the treatment was reported as modest and of short duration (8).
Another aspect to be considered is the cost per IV catheter insertion with both methods. In our institution, the cost of using the J-Tip® is $2.10 compared to $2.80 for EMLA® at hospital acquired price. The use of the J-Tip® does not increase costs and could be implemented as an alternative method.
The lack of needle involvement and quick onset of action in addition to the effectiveness for providing adequate analgesia before cannulation make the J-Tip® a valuable resource in pediatric anesthesia practice. Its use could be especially helpful in emergency situations or busy ambulatory settings in which there is not enough time for effective EMLA® application. Because it does not involve needle handling, the J-Tip® may decrease the risk of needle-stick injury and the potential for contamination.
The authors thank the nursing and physician staff for their assistance in completing the cannulation assessments. We also thank Tom Thomason (Justlin Medical Inc, Woodinville, Washington) for supplying the J-Tip® syringes for use in this study.
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Footnotes
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Tom Thomason (Justlin Medical Inc, Woodinville, WA) supplied the J-Tip syringes for use in this study.
Accepted for publication September 16, 2005.
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References
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- Lander J, Hodgins M, Nazarali S, et al. Determinants of success and failure of EMLA. Pain 1996;64:89–97.[ISI][Medline]
- Galinkin JL, Rose JB, Harris K, Watcha MF. Lidocaine iontophoresis versus eutectic mixture of local anesthetic (EMLA®) for IV placement in children. Anesth Analg 2002;94:1484–8.[Abstract/Free Full Text]
- Browne J, Awad I, Plant R, et al. Topical amethocaine (AmetopTM) is superior to EMLA for intravenous cannulation. Can J Anaesth 1999;46:1014–18.[Abstract/Free Full Text]
- Bjerring P, Andersen PH, Arendt-Nielsen L. Vascular response of human skin after analgesia with EMLA cream. Br J Anaesth 1989;63:655–60.[Abstract/Free Full Text]
- Jennison C, Turnbull B. Group sequential methods with applications to clinical trials. 1st ed. London/New York: Chapman & Hall, 2000.
- Cooper JA, Bromley LM, Baranowski AP, Barker SGE. Evaluation of a needle-free injection system for local anesthesia prior to venous cannulation. Anaesthesia 2000;55:247–50.[ISI][Medline]
- Lysakowski C, Dumont L, Tramer MR, Tassonyi E. A needle-free jet injection system with lidocaine for peripheral intravenous cannula insertion: a randomized control trial with cost-effectiveness analysis. Anesth Analg 2003;96:215–9.[Abstract/Free Full Text]
- Fine B, Castillo R, McDonald T, et al. Jet injector compared with oral midazolam for preoperative sedation in children. Paediatr Anaesth 2004;14:739–43.[Medline]
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Abstract
Introduction
