Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
Minor needlestick procedures often cause significant pain and distress in pediatric patients
yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,
prefilled, needle-free product that immediately delivers powdered lidocaine into the
epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III,
prospective, randomized, double-blind, placebo-controlled study is to investigate the
efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3
to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial
will enroll approximate 504 evaluable subjects at centers located in the US.