Randomized, double-blind, placebo-controlled study of ALGRX 3268: A topical lidocaine delivery system for topical anesthesia prior to venipuncture in children

Abstract

ALGRX 3268 is a needle-free product that accelerates lidocaine into the skin under pressure of helium gas to provide topical anesthesia within 1 minute. In this single center, randomized, double-blind, placebo controlled trial, ALGRX 3268 (0.5 mg lidocaine delivered at 20 bar) or matching placebo was administered to 306 children ages 3–18 prior to venipuncture. Pain was assessed by children after ALGRX 3268 administration and after venipuncture performed at the back of the hand. Pain assessment was performed 2–3 minutes after venipuncture.