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用于皮肤裂伤修复过程中疼痛控制的局部麻醉剂。

Topical anaesthetics for pain control during repair of dermal laceration.

作者信息

Tayeb Baraa O, Eidelman Anthony, Eidelman Cristy L, McNicol Ewan D, Carr Daniel B

机构信息

Pain Research, Education and Policy (PREP) Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Avenue, Stearns 203, Boston, Massachusetts, USA.

College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

出版信息

Cochrane Database Syst Rev. 2017 Feb 22;2(2):CD005364. doi: 10.1002/14651858.CD005364.pub3.

Abstract

BACKGROUND

Topical local anaesthetics provide effective analgesia for patients undergoing numerous superficial procedures, including repair of dermal lacerations. The need for cocaine in topical anaesthetic formulations has been questioned because of concern about adverse effects, thus novel preparations of cocaine-free anaesthetics have been developed. This review was originally published in 2011 and has been updated in 2017.

OBJECTIVES

To assess whether benefits of non-invasive topical anaesthetic application occur at the expense of decreased analgesic efficacy. To compare the efficacy of various single-component or multi-component topical anaesthetic agents for repair of dermal lacerations. To determine the clinical necessity for topical application of the ester anaesthetic, cocaine.

SEARCH METHODS

For this updated review, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11), Cumulative Index to Nursing and Allied Health Literature (CINAHL; 2010 to December 2016), Embase (2010 to December 2016) and MEDLINE (2010 to December 2016). We did not limit this search by language or format of publication. We contacted manufacturers, international scientific societies and researchers in the field. Weemailed selected journalsand reviewed meta-registers of ongoing trials. For the previous version of this review, we searched these databases to November 2010.

SELECTION CRITERIA

We included randomized controlled trials (RCTs) that evaluated the efficacy and safety of topical anaesthetics for repair of dermal laceration in adult and paediatric participants.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information when needed. We collected adverse event information from trial reports. We assessed methodological risk of bias for each included study and employed the GRADE approach to assess the overall quality of the evidence.

MAIN RESULTS

The present updated review included 25 RCTs involving 3278 participants. The small number of trials in each comparison group and the heterogeneity of outcome measures precluded quantitative analysis of data for all but one outcome: pain intensity. In two pooled studies, the mean self-reported visual analogue scale (VAS; 0 to 100 mm) score for topical prilocaine-phenylephrine (PP) was higher than the mean self-reported VAS (0 to 100 mm) score for topical tetracaine-epinephrine-cocaine (TAC) by 5.59 points (95% confidence interval (CI) 2.16 to 13.35). Most trials that compared infiltrated and topical anaesthetics were at high risk of bias, which is likely to have affected their results. Researchers found that several cocaine-free topical anaesthetics provided effective analgesic efficacy. However, data regarding the efficacy of each topical agent are based mostly on single comparisons in trials with unclear or high risk of bias. Mild, self-limited erythematous skin induration occurred in one of 1042 participants who had undergone application of TAC. Investigators reported no serious complications among any of the participants treated with cocaine-based or cocaine-free topical anaesthetics. The overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.

AUTHORS' CONCLUSIONS: We have found two new studies published since the last version of this review was prepared. We have added these studies to those previously included and have conducted an updated analysis, which resulted in the same review conclusions as were presented previously.Mostly descriptive analysis indicates that topical anaesthetics may offer an efficacious, non-invasive means of providing analgesia before suturing of dermal lacerations. Use of cocaine-based topical anaesthetics might be hard to justify, given the availability of other effective topical anaesthetics without cocaine. However, the overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.

摘要

背景

局部麻醉剂可为接受多种浅表手术(包括皮肤裂伤修复)的患者提供有效的镇痛效果。由于担心不良反应,局部麻醉剂配方中使用可卡因的必要性受到质疑,因此已开发出不含可卡因的新型麻醉剂制剂。本综述最初发表于2011年,并于2017年更新。

目的

评估无创局部麻醉应用的益处是否是以镇痛效果降低为代价。比较各种单组分或多组分局部麻醉剂用于修复皮肤裂伤的疗效。确定局部应用酯类麻醉剂可卡因的临床必要性。

检索方法

对于本次更新的综述,我们检索了以下数据库:Cochrane对照试验中心注册库(CENTRAL;2016年第11期)、护理及相关健康文献累积索引(CINAHL;2010年至2016年12月)、Embase(2010年至2016年12月)和MEDLINE(2010年至2016年12月)。我们没有根据语言或出版物格式对此次检索进行限制。我们联系了制造商、国际科学协会和该领域的研究人员。我们给选定的期刊发了电子邮件,并查阅了正在进行试验的元注册库。对于本综述的上一版本,我们检索这些数据库至2010年11月。

入选标准

我们纳入了评估局部麻醉剂对成人和儿童参与者皮肤裂伤修复的疗效和安全性的随机对照试验(RCT)。

数据收集与分析

两位综述作者独立评估试验质量并提取数据。必要时,我们联系研究作者以获取更多信息。我们从试验报告中收集不良事件信息。我们评估了每项纳入研究的方法学偏倚风险,并采用GRADE方法评估证据的整体质量。

主要结果

本次更新的综述纳入了25项RCT,涉及3278名参与者。每个比较组中的试验数量较少以及结局指标的异质性使得除疼痛强度这一结局外,无法对所有数据进行定量分析。在两项汇总研究中,局部应用丙胺卡因 - 去氧肾上腺素(PP)的平均自我报告视觉模拟量表(VAS;0至100毫米)评分比局部应用丁卡因 - 肾上腺素 - 可卡因(TAC)的平均自我报告VAS(0至100毫米)评分高5.59分(95%置信区间(CI)2.16至13.35)。大多数比较浸润麻醉和局部麻醉的试验存在较高的偏倚风险,这可能影响了它们的结果。研究人员发现,几种不含可卡因的局部麻醉剂具有有效的镇痛效果。然而,关于每种局部麻醉剂疗效的数据大多基于偏倚风险不明确或较高的试验中的单一比较。在1042名接受TAC应用的参与者中,有1人出现轻度、自限性的红斑性皮肤硬结。研究人员报告,在接受基于可卡因或不含可卡因的局部麻醉剂治疗的所有参与者中均未出现严重并发症。根据GRADE系统,由于设计和实施方面的局限性、结果的不精确性以及发表偏倚(数据的选择性报告)的高可能性,证据的整体质量较低。在得出明确结论之前,需要进行更多设计良好、偏倚风险低的RCT。

作者结论

自本综述的上一版本编写以来,我们发现了两项新研究。我们将这些研究添加到先前纳入的研究中,并进行了更新分析,得出了与之前相同的综述结论。大多数描述性分析表明,局部麻醉剂可能为皮肤裂伤缝合前提供镇痛效果提供一种有效、无创的方法。鉴于有其他不含可卡因的有效局部麻醉剂,使用基于可卡因的局部麻醉剂可能难以自圆其说。然而,根据GRADE系统,由于设计和实施方面的局限性、结果的不精确性以及发表偏倚(数据的选择性报告)的高可能性,证据的整体质量较低。在得出明确结论之前,需要进行更多设计良好、偏倚风险低的RCT。

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