Study of ALGRX 3268 for Needlestick Pain in Children
Status:
Completed
Trial end date:
2004-09-01
Target enrollment:
Participant gender:
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.