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Contribution of a Heating Element to Topical Anesthesia Patch Efficacy Prior to Vascular Access: Results From Two Randomized, Double-Blind Studies.

Author(s): Masud S, Wasnich RD, Ruckle JL, Garland WT, Halpern SW, Mee-Lee D, Ashburn MA, Campbell JC

Affiliation(s): Shriners Hospitals for Children (S.M.), and Department of Anesthesiology (S.M.), University of Utah, Salt Lake City, Utah; John A. Burns School of Medicine (R.D.W.), University of Hawaii, Honolulu, Hawaii; Covance Clinical Research Unit (J.L.R.), Honolulu, Hawaii; PharmaNet, Inc. (W.T.G.), San Diego, California; Radiant Research (S.W.H.), Santa Rosa, California; Hawaii Clinical Research Center (D.M.-L.), Honolulu, Hawaii; Department of Anesthesiology and Critical Care (M.A.A.), University of Pennsylvania, Penn Pain Medicine Center, Philadelphia, Pennsylvania; and Endo Pharmaceuticals (J.C.C.), Chadds Ford, Pennsylvania, USA.

Publication date & source: 2010-07-31, J Pain Symptom Manage., [Epub ahead of print]

CONTEXT: Pain associated with superficial procedures, including intravenous (IV) access procedures, should be prevented when possible, especially in children. OBJECTIVES: To evaluate a topical local anesthetic patch containing lidocaine 70mg/tetracaine 70mg with a heating element designed to warm the skin and facilitate rapid delivery of local anesthetics into the skin. The pilot study was designed to provide data to inform the design of the definitive study to evaluate the impact of controlled heat on the efficacy of the lidocaine/tetracaine patch (patch) when applied before IV cannulation. METHODS: Subjects in the pilot study were randomized to eight groups that varied by heated vs. unheated patch, 20 vs. 30 minute application, and 16 vs. 18 G catheter. Subjects in the definitive study were randomized in a double-blind manner to receive either the heated or unheated patch, 20 minutes before vascular access, using a 16 G catheter in the antecubital space of the arm. In both studies, the primary efficacy measure was subject-reported pain intensity using the visual analog scale. RESULTS: Pilot study: Subjects who received the heated patch (n=43) vs. the unheated patch (n=37) had lower mean pain intensity scores (14.7 vs. 23.5mm, P=0.04). Pain intensity scores did not differ significantly by application time, but the difference between the 16 and 18 G catheter groups approached statistical significance (22.8 vs. 14.9mm, P=0.05). Definitive study: Mean pain intensity scores for the heated patch group (n=124) vs. the unheated patch group (n=126) were 14.2 and 20.5mm, respectively (P=0.006). CONCLUSION: Heated patches provided significantly better pain relief compared with unheated patches. All the subjects tolerated the patches well, with few adverse effects. Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Page last updated: 2010-10-05

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