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一项比较新型局部麻醉膏敷贴和利多卡因浸润用于治疗急诊科撕裂伤的麻醉效果的非劣效性随机对照试验。

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.

机构信息

Department of Emergency Medicine, Antrim Area Hospital, Antrim, UK.

School of Pharmacy, Queen's University Belfast, Medical Biology Centre, Belfast, UK.

出版信息

Ann Emerg Med. 2014 Jun;63(6):704-10. doi: 10.1016/j.annemergmed.2013.12.012. Epub 2014 Jan 15.

DOI:10.1016/j.annemergmed.2013.12.012
PMID:24439713
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.

摘要

研究目的

我们通过试验假设,即新型局部麻醉膏诱导的麻醉(疼痛评分)与常规利多卡因浸润麻醉(用于修复撕裂伤)在效果上无差异(边际值=1.3),来验证该假设。

方法

在当地医院的急诊室(ED)进行了一项随机对照试验。参与者按照试验方案被随机分配接受浸润麻醉或局部麻醉膏。在浸润后 15 分钟和局部麻醉膏应用后 30 分钟记录疼痛评分。比较两组的中位数疼痛评分。在 7 至 10 天后进行伤口评估评分,并监测两组参与者在整个研究期间的不良事件。

结果

本研究共纳入 110 名参与者,其中 56 名接受浸润麻醉,54 名接受局部麻醉膏。两组的疼痛评分中位数差异为 0(95%置信区间-1 至 0)。两组在伤口评估评分或不良事件发生率方面均无显著差异。

结论

新型局部麻醉膏在缝合时的疼痛缓解方面并不逊于浸润麻醉,且在 ED 中,这种麻醉膏是一种可行的替代浸润麻醉的选择。

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