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在接受静脉穿刺的成年人中比较蒸发冷却液喷雾与安慰剂喷雾的前瞻性、随机、双盲对照试验。

Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture.

作者信息

Mace Sharon E

机构信息

Department of Emergency Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, MetroHealth Medical Center Emergency Medicine Residency, Research, Emergency Services Institute, Cleveland Clinic, Cleveland, OH.

出版信息

Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.

DOI:10.1016/j.ajem.2016.01.002
PMID:26979261
Abstract

INTRODUCTION

Topical anesthetics are used to decrease procedural pain such as venipuncture. Advantages of vapocoolants include rapid onset, ease of application, low cost, and lack of associated pain of injection and other needlestick-related risks. We hypothesized that the pain of venipuncture would be reduced by at least 1.8 points on a 10-point numerical rating scale after application of a vapocoolant compared with placebo.

METHODS

We conducted a prospective, randomized, double-blind controlled trial of vapocoolant vs placebo spray in 100 adults (ages 18-80) requiring venipuncture in a hospital emergency department or observation unit. The primary efficacy outcome was the difference in pain scores immediately after venipuncture, measured on a 10-point verbal numeric rating scale from 0 (none) to worst (10). Safety outcomes included local adverse effects (edema, erythema, blanching) and changes in vital signs (VS).

RESULTS

Patient characteristics and venipuncture procedure were not significantly different for the 2 groups. The median (interquartile range) pain of venipuncture was 3 (1.2-5) in the placebo group and 1 (0-3) in the vapocoolant group, P < .001. Skin checklist revealed the following: vapocoolant-minimal blanching 4%, minimal erythema 18% which resolved within 5 minutes; placebo-no visible skin changes. Photographs at 5 to 10 minutes revealed no visible skin changes in any patient. There were 2 complaints: "very wet and cold on skin" (placebo) and "felt burning on skin" (vapocoolant).

CONCLUSION

The vapocoolant significantly decreased venipuncture pain in adults compared with placebo and was well tolerated with minor adverse effects that resolved quickly. There were no significant differences in VS and no visible skin changes documented at the site by photographs taken within 5 to 10 minutes postspray/venipuncture.

摘要

引言

局部麻醉剂用于减轻诸如静脉穿刺等操作过程中的疼痛。冷雾剂的优点包括起效迅速、易于使用、成本低廉,且不存在注射相关疼痛及其他针刺相关风险。我们假设,与安慰剂相比,使用冷雾剂后,静脉穿刺疼痛在10分数字评分量表上至少降低1.8分。

方法

我们在一家医院急诊科或观察病房对100名需要进行静脉穿刺的18至80岁成年人进行了一项前瞻性、随机、双盲对照试验,比较冷雾剂与安慰剂喷雾。主要疗效指标是静脉穿刺后立即的疼痛评分差异,采用从0(无疼痛)至最严重(10)的10分语言数字评分量表进行测量。安全性指标包括局部不良反应(水肿、红斑、皮肤变白)和生命体征(VS)变化。

结果

两组患者的特征和静脉穿刺操作无显著差异。安慰剂组静脉穿刺疼痛的中位数(四分位间距)为3(1.2 - 5),冷雾剂组为1(0 - 3),P < 0.001。皮肤检查表显示如下:冷雾剂组 - 轻微皮肤变白4%,轻微红斑18%,5分钟内消退;安慰剂组 - 无可见皮肤变化。5至10分钟时的照片显示,所有患者均无可见皮肤变化。有2例主诉:“皮肤非常湿冷”(安慰剂组)和“皮肤有烧灼感”(冷雾剂组)。

结论

与安慰剂相比,冷雾剂显著减轻了成年人的静脉穿刺疼痛,耐受性良好,不良反应轻微且迅速消退。生命体征无显著差异,喷雾/静脉穿刺后5至10分钟拍摄的照片显示穿刺部位无可见皮肤变化。

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