NCT00132405

Study of ALGRX 3268 for Needlestick Pain in Children

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (planned)
• Sponsor: AlgoRx Pharmaceuticals · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	ALGRX 3268

Timeline

• Start date: 2004-05-01
• Completion: 2004-09-01
• First posted: 2005-08-22
• Last updated: 2005-10-10

Locations

1 site across 1 country: United States