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The Journal of pediatrics · Mar 2008
Randomized Controlled TrialA novel needle-free powder lidocaine delivery system for rapid local analgesia.
- William T Zempsky, Bertha Robbins, Patricia T Richards, Michael S Leong, and Neil L Schechter.
- Pain Relief Program, Connecticut Children's Medical Center, Hartford, CT, USA.
- J. Pediatr. 2008 Mar 1;152(3):405-11.
ObjectiveTo determine the analgesic effect and tolerability of a novel needle-free powder lidocaine delivery system in children undergoing venipuncture.Study DesignIn this double-blind, placebo-controlled, single-center trial, 306 children age 3 to 18 years were randomized to receive a needle-free powder lidocaine delivery system or matching sham placebo at the back of the hand 2 to 3 minutes before venipuncture. Venipuncture pain was self-reported using the Wong-Baker FACES scale (in 3- to 12-year-olds) and a 100-mm visual analog scale (in 8- to 18-year-olds). Safety was assessed by adverse events, investigator skin site assessments, and children's self-report of the administration comfort of study treatments. Effect sizes were compared by 2-sample t test and Glass's Delta approach.ResultsSubjects receiving the needle-free powder lidocaine delivery system exhibited mean pain reductions (effect size) of 33% to 46% relative to sham placebo. Pain reductions were statistically significant for all ages combined and also for the youngest and oldest age strata. Self-reported administration comfort levels were similar in the active system and sham placebo groups. Incidences of adverse events and dermal reactions were low; the most common dermal reaction was mild erythema.ConclusionsThe needle-free powder lidocaine delivery system was well tolerated and provided effective local analgesia when administered 2 to 3 minutes before venipuncture.
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