A novel needle-free powder lidocaine delivery system for rapid local analgesia.
OBJECTIVE
To determine the analgesic effect and tolerability of a novel needle-free powder lidocaine delivery system in children undergoing venipuncture.


METHODS
In 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.


RESULTS
Subjects 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.


CONCLUSIONS
The needle-free powder lidocaine delivery system was well tolerated and provided effective local analgesia when administered 2 to 3 minutes before venipuncture.
Zempsky
William T
WT
Pain Relief Program, Connecticut Children's Medical Center, Hartford, CT, USA.
Robbins
Bertha
B
Richards
Patricia T
PT
Leong
Michael S
MS
Schechter
Neil L
NL
D000293:Adolescent; D000367:Age Factors; D000772:Anesthesia, Local / Q000379:methods*; D000779:Anesthetics, Local / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012737:Sex Factors; D016896:Treatment Outcome
D000779:Anesthetics, Local; D008012:Lidocaine