A Non-Inferiority Randomized Controlled Trial Comparing the Clinical Effectiveness of Anesthesia Obtained by Application of a Novel Topical Anesthetic Putty With the Infiltration of Lidocaine for the Treatment of Lacerations in the Emergency Department

Mark Jenkins, Diarmaid Murphy, Carol Little, Julie McDonald, Paul McCarron

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Study objectiveWe test the hypothesis that anesthesia, measured as pain scores, induced by a novel topical anesthetic putty is non-inferior (margin=1.3) to that provided by conventional lidocaine infiltration for the repair of lacerations.MethodsA randomized controlled trial was conducted in the emergency department (ED) of a local hospital. Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol. Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application. Median pain scores were compared between groups. Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study.ResultsOne hundred and ten participants were enrolled in the study, with 56 receiving infiltration and 54 receiving topical anesthetic putty. The median difference between the pain scores of the 2 groups was 0 (95% confidence interval –1 to 0). There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events.ConclusionThe novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing, and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED.
LanguageEnglish
Pages704-710
JournalAnnals of Emergency Medicine
Volume63
Issue number6
Early online date17 Jan 2014
DOIs
Publication statusE-pub ahead of print - 17 Jan 2014

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Lacerations
Lidocaine
Local Anesthetics
Hospital Emergency Service
Anesthesia
Pain
Local Anesthesia
Therapeutics
Wounds and Injuries
Clinical Protocols
Randomized Controlled Trials
Non-Randomized Controlled Trials
Confidence Intervals
Incidence

Keywords

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Cite this

@article{6f6db7cb504e4acfa3b94934c77f0b18,
title = "A Non-Inferiority Randomized Controlled Trial Comparing the Clinical Effectiveness of Anesthesia Obtained by Application of a Novel Topical Anesthetic Putty With the Infiltration of Lidocaine for the Treatment of Lacerations in the Emergency Department",
abstract = "Study objectiveWe test the hypothesis that anesthesia, measured as pain scores, induced by a novel topical anesthetic putty is non-inferior (margin=1.3) to that provided by conventional lidocaine infiltration for the repair of lacerations.MethodsA randomized controlled trial was conducted in the emergency department (ED) of a local hospital. Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol. Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application. Median pain scores were compared between groups. Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study.ResultsOne hundred and ten participants were enrolled in the study, with 56 receiving infiltration and 54 receiving topical anesthetic putty. The median difference between the pain scores of the 2 groups was 0 (95{\%} confidence interval –1 to 0). There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events.ConclusionThe novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing, and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED.",
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author = "Mark Jenkins and Diarmaid Murphy and Carol Little and Julie McDonald and Paul McCarron",
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language = "English",
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T1 - A Non-Inferiority Randomized Controlled Trial Comparing the Clinical Effectiveness of Anesthesia Obtained by Application of a Novel Topical Anesthetic Putty With the Infiltration of Lidocaine for the Treatment of Lacerations in the Emergency Department

AU - Jenkins, Mark

AU - Murphy, Diarmaid

AU - Little, Carol

AU - McDonald, Julie

AU - McCarron, Paul

PY - 2014/1/17

Y1 - 2014/1/17

N2 - Study objectiveWe test the hypothesis that anesthesia, measured as pain scores, induced by a novel topical anesthetic putty is non-inferior (margin=1.3) to that provided by conventional lidocaine infiltration for the repair of lacerations.MethodsA randomized controlled trial was conducted in the emergency department (ED) of a local hospital. Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol. Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application. Median pain scores were compared between groups. Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study.ResultsOne hundred and ten participants were enrolled in the study, with 56 receiving infiltration and 54 receiving topical anesthetic putty. The median difference between the pain scores of the 2 groups was 0 (95% confidence interval –1 to 0). There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events.ConclusionThe novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing, and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED.

AB - Study objectiveWe test the hypothesis that anesthesia, measured as pain scores, induced by a novel topical anesthetic putty is non-inferior (margin=1.3) to that provided by conventional lidocaine infiltration for the repair of lacerations.MethodsA randomized controlled trial was conducted in the emergency department (ED) of a local hospital. Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol. Pain scores were recorded 15 minutes after infiltration and 30 minutes after topical anesthetic putty application. Median pain scores were compared between groups. Wound evaluation scores were conducted after 7 to 10 days and adverse events were monitored for both groups of participants throughout the study.ResultsOne hundred and ten participants were enrolled in the study, with 56 receiving infiltration and 54 receiving topical anesthetic putty. The median difference between the pain scores of the 2 groups was 0 (95% confidence interval –1 to 0). There were no substantial differences between the 2 groups in terms of either the wound evaluation scores or the incidence of adverse events.ConclusionThe novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing, and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED.

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