Use of the Synera™ Patch for Local Anesthesia Before Vascular Access Procedures: A Randomized, Double-Blind, Placebo-Controlled Study

ABSTRACT Objective. This randomized, double‐blind, placebo‐controlled, paired study compared the Synera™ patch, a drug delivery device comprised of an eutectic mixture of lidocaine (70 mg) and tetracaine (70 mg) whose onset is accelerated by a controlled heating device, with placebo. The objective of the study was to evaluate the efficacy of Synera in inducing local anesthesia before a vascular access procedure. Design. Before the vascular access procedures, adult volunteers randomly received a concurrent application of Synera and placebo to the right and left antecubital surfaces. Forty subjects received 20‐minute treatments. After each vascular access procedure, efficacy evaluations were completed by the subject, investigator, and an independent observer. Median subject‐reported pain intensity, using the visual analog scale scores (VAS, 0–100 mm scale) were significantly lower for Synera than placebo (5 mm vs 28 mm, P