Study of ALGRX 3268 for Needlestick Pain in Children

Pain Clinical Trial

Official title: Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effectiveness and Safety of ALGRX 3268 0.5 Mg/20 Bar at the Back of the Hand in Pediatric Subjects

Status Completed

Clinical Trial Summary

Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective, randomized, double-blind, and placebo-controlled trial is to determine the efficacy and tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of the back of the hand at a single study center.

Clinical Trial Description

ALGRX 3268 (previously known as PowderJect® Dermal Lidocaine) is a system for needle-free, pain-free epidermal injection of lidocaine powder that provides local anesthesia within 3 minutes to provide painless needle or catheter insertion for blood drawing. ALGRX 3268 is a single use disposable system, incorporating a drug cassette and gas cylinder into a single hand held device, with a button to actuate the system. This is a single center, randomized, double-blind, placebo (sham) controlled, single dose, parallel group study in pediatric subjects scheduled to undergo venipuncture. Three age groups are enrolled: 3-7 years, 8-12 years, and 13-18 years. Within each age group, subjects are randomized to receive ALGRX 3268 0.5 mg/20 bar or pressure matched placebo. Two to 3 minutes after administration of study treatment at the back of the hand, venipuncture is performed with either a needle/Vacutainer®, needle/syringe or "butterfly," at the discretion of the investigator. Subjects aged 3-7 are asked to rate the pain of venipuncture using the Wong-Baker FACES Pain Rating Scale, anchored at 0 for "no hurt" and 5 for "hurts worst." Subjects in oldest age group complete a 100 mm visual analogue scale (VAS), anchored at 0 for "no pain" and at 100 for "extreme pain." Subjects in the middle group used both the Wong-Baker FACES scale and the VAS to rate the pain of venipuncture. Safety ratings of skin are completed 15, 30, and 60 minutes after the procedure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

• NCT number: NCT00132405
• Study type: Interventional
• Source: AlgoRx Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: May 2004
• Completion date: September 2004