Rapid, Needle-Free Delivery of Lidocaine for Reducing the Pain of Venipuncture Among Pediatric Subjects

Abstract

Objectives. The purpose of this study was to determine the optimal configuration of an investigational, single-use, needle-free, drug system (ALGRX 3268) that delivers powdered lidocaine into the epidermis for the rapid production of local anesthesia among pediatric subjects undergoing venipuncture. Methods. Children 3 to 18 years of age were randomly allocated to receive 1 of 3 treatments, ie, (1) placebo, (2) a system configured to deliver 0.25 mg of lidocaine, or (3) a system configured to deliver 0.5 mg of lidocaine, at the antecubital fossa 2 to 3 minutes before venipuncture. Three age groups were included, ie, 3 to 7 years, 8 to 12 years, and 13 to 18 years. Two sets of pain rating scales were used, the Faces Pain Scale-Revised for the youngest age stratum and a visual analog scale for the oldest age stratum. Children in the middle age stratum used both scales. Results. One-hundred forty-four subjects completed the study. For all ages combined, there was a statistically significant and clinically meaningful reduction in pain scores for subjects who received 0.5 mg of lidocaine, compared with placebo. The reduction in pain after 0.25 mg of lidocaine did not achieve statistical significance. Conclusions. Both active configurations were safe and well tolerated by pediatric subjects undergoing venipuncture at the antecubital fossa. ALGRX 3268 at 0.5 mg, administered 2 to 3 minutes before venipuncture, produced significantly lower pain scores, compared with placebo.