Document Detail


A novel needle-free powder lidocaine delivery system for rapid local analgesia.
MedLine Citation:
PMID:  18280850     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To determine the analgesic effect and tolerability of a novel needle-free powder lidocaine delivery system in children undergoing venipuncture. STUDY DESIGN: 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.
Authors:
William T Zempsky; Bertha Robbins; Patricia T Richards; Michael S Leong; Neil L Schechter
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-10-22
Journal Detail:
Title:  The Journal of pediatrics     Volume:  152     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-02-18     Completed Date:  2008-03-18     Revised Date:  2008-09-30    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  405-11     Citation Subset:  AIM; IM    
Affiliation:
Pain Relief Program, Connecticut Children's Medical Center, Hartford, CT, USA.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Age Factors
Anesthesia, Local / methods*
Anesthetics, Local / administration & dosage*
Child
Child, Preschool
Confidence Intervals
Double-Blind Method
Drug Delivery Systems
Female
Follow-Up Studies
Humans
Lidocaine / administration & dosage*
Male
Pain / drug therapy*
Pain Measurement
Prospective Studies
Reference Values
Risk Assessment
Sex Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anesthetics, Local; 137-58-6/Lidocaine
Comments/Corrections
Comment In:
Evid Based Nurs. 2008 Oct;11(4):106   [PMID:  18815318 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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