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比较酮咯酸和对乙酰氨基酚对冠状动脉搭桥手术后疼痛缓解的效果。一项随机临床试验。

Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.

作者信息

Javaherforooshzadeh Fatemeh, Abdalbeygi Hasan, Janatmakan Farahzad, Gholizadeh Behnam

机构信息

Department of Cardiac Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

J Cardiothorac Surg. 2020 May 11;15(1):80. doi: 10.1186/s13019-020-01125-y.

Abstract

INTRODUCTION

Pain management after coronary artery bypass graft (CABG) surgery remains challenging.

OBJECTIVE

This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief.

METHOD

This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery.

INTERVENTION

The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction.

STATISTICAL ANALYSIS

The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05.

RESULTS

Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables.

CONCLUSION

The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief.

TRIAL REGISTRY

IRCT20150216021098N5. Registered at 2019-09-12.

摘要

引言

冠状动脉旁路移植术(CABG)后的疼痛管理仍然具有挑战性。

目的

本研究旨在比较酮咯酸和对乙酰氨基酚对CABG术后疼痛缓解的效果。

方法

这项双盲随机临床试验于2018年9月至2019年12月在伊朗阿瓦士进行。连续两组,每组60例接受择期体外循环冠状动脉旁路移植手术的患者。

干预措施

术后将患者分为接受0.5mg/kg酮咯酸mg/dl和10mg/kg对乙酰氨基酚进行疼痛管理。主要结局指标为:拔管后即刻(基线)、6、12、24和48小时的视觉模拟疼痛量表(VAS)评分以及吗啡总消耗量。次要结局指标包括血流动力学变量、脱机时间、胸管引流、住院死亡率和心肌梗死。

统计分析

使用SPSS 22版(SPSS,伊利诺伊州芝加哥)对数据进行分析。采用曼-惠特尼U检验比较人口统计学数据、VAS评分、生命体征和副作用。组内重复测量采用弗里德曼方差分析和威尔科克森秩和检验。数值以均值±标准差表示。统计学显著性定义为p值<0.05。

结果

与基线评分相比,两组在整个时间序列中的VAS评分均显著下降(P<0.05)。除6小时外,对乙酰氨基酚组在大多数时间点的统计学VAS评分略高。然而,在24和48小时时,对乙酰氨基酚组的VAS评分显著高于酮咯酸组。两组在血流动力学变量方面无显著差异。

结论

酮咯酸在CABG术后疼痛缓解方面的疗效与对乙酰氨基酚相当。

试验注册

IRCT20150216021098N5。于2019年9月12日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e10/7216617/d9006609d31b/13019_2020_1125_Fig1_HTML.jpg

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