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日间手术中达到满意镇痛且最小化呕吐发生率:吗啡与氢吗啡酮的随机对照试验。

Satisfactory analgesia with minimal emesis in day surgeries: a randomised controlled trial of morphine versus hydromorphone.

机构信息

Department of Anesthesia, St Joseph's Healthcare, McMaster University, Canada.

Department of Anesthesia, McMaster University, Canada.

出版信息

Br J Anaesth. 2019 Jun;122(6):e107-e113. doi: 10.1016/j.bja.2019.03.036. Epub 2019 Apr 23.

Abstract

BACKGROUND

Opioids remain the mainstay therapy for post-surgical pain. Although both morphine and hydromorphone are potent analgesics, it has been suggested that hydromorphone is clinically better. Our primary objective was to compare morphine with hydromorphone for achieving satisfactory analgesia with minimal emesis (SAME).

METHODS

We performed a multicentre RCT in 402 patients having ambulatory surgery. A random computer-generated allocation, stratified by site, was developed by our pharmacy. Concealment was achieved by allocating patients to study groups by nurses using sequentially coded study medication syringes having equi-analgesic doses, made available in the postoperative recovery room. Patients, health providers, and research personnel were blinded. The operating-room protocol allowed for routine anaesthetic management, excluding the use of study medications. Study medications were administered by recovery nurses as per an algorithm. Analyses utilised the intention-to-treat principle, and regression analyses were used for outcomes as appropriate and using multiple imputation.

RESULTS

Of 751 patients, 402 were randomised between morphine (n=199) and hydromorphone (n=203). Baseline and intraoperative variables were comparable across the groups. The odds of achieving SAME were similar between the groups (odds ratio: 1.01; 95% confidence interval: 0.57-1.80). There were no differences in the side-effects of severe itching, respiratory depression, or sedation. Patient satisfaction, discharge times, and post-discharge outcomes, including pain and nausea/vomiting over 24 h, were also comparable.

CONCLUSIONS

There was no difference between morphine and hydromorphone regarding analgesia and common side-effects. The appearance of dose-limiting side-effects is idiosyncratic; the clinical decision must be based on individual responses.

CLINICAL TRIAL REGISTRATION

NCT02223377.

摘要

背景

阿片类药物仍然是术后疼痛的主要治疗方法。虽然吗啡和氢吗啡酮都是强效镇痛药,但有人认为氢吗啡酮在临床上更好。我们的主要目标是比较吗啡和氢吗啡酮在实现满意镇痛和最小呕吐(SAME)方面的效果。

方法

我们在 402 名接受门诊手术的患者中进行了一项多中心 RCT。我们的药房通过按地点分层的随机计算机生成分配方案来制定随机分配。通过护士使用具有等效镇痛剂量的连续编码研究药物注射器将患者分配到研究组来实现隐匿,这些注射器在术后恢复室提供。患者、医疗服务提供者和研究人员均处于盲态。手术室方案允许进行常规麻醉管理,但不包括使用研究药物。恢复护士根据算法给予研究药物。分析采用意向治疗原则,对于适当的结果采用回归分析,并使用多重插补。

结果

在 751 名患者中,有 402 名患者被随机分为吗啡(n=199)和氢吗啡酮(n=203)组。两组的基线和术中变量无差异。两组实现 SAME 的可能性相似(优势比:1.01;95%置信区间:0.57-1.80)。严重瘙痒、呼吸抑制或镇静等副作用无差异。患者满意度、出院时间以及出院后 24 小时内的疼痛和恶心/呕吐等结果也无差异。

结论

吗啡和氢吗啡酮在镇痛和常见副作用方面无差异。出现剂量限制副作用是因人而异的;临床决策必须基于个体反应。

临床试验注册

NCT02223377。

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