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 - 19/05/14
Abstract |
Study objective |
We 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.
Methods |
A 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.
Results |
One 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.
Conclusion |
The 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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| Supervising editor: Steven M. Green, MD |
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| Author contributions: MGJ and PAM were responsible for devising and constructing the trial, with all necessary ethical approval and governance managed by MGJ and DJM. DJM and PAM were responsible for pharmaceutical development and manufacture of putty samples. CL and JM were responsible for patient management and data collection in the ED, with MGJ providing clinical oversight. DJM was responsible for initial drafting of the article, with final editing completed by MGJ and PAM. MGJ and DJM were responsible for statistical analysis of the data, with assistance provided by the Northern Ireland Clinical Research Support Centre. MGJ takes responsibility for the paper as a whole. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The wound putty used in this study is not a proprietary product and is not produced commercially. The putty was manufactured by Drs. Murphy and McCarron. After the success of this trial, Drs. Jenkins and McCarron sought to protect certain aspects of the putty formulation in both the United States and Europe. This patent application is pending and relates to a certain aspect of the formulation that enables the lidocaine to be included. Drs. Jenkins and McCarron are pursuing sources of capital to commercialize the putty but have not secured this funding. We confirm that the authors of this study did not receive any funding from commercial sources to support the study. The funding used to sustain this study was obtained by a peer-reviewed competitive process from the Public Health Agency in Northern Ireland. This is a governmental organization with no commercial links. The authors are not receiving income streams from licensing arrangements or royalties. Supported by the Research and Development Office (Northern Ireland) Trauma and Rehabilitation Recognised Research Group (RRG 8.46 RRG/3273/06). |
Vol 63 - N° 6
P. 704-710 - juin 2014 Retour au numéro
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