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单次预防性静脉注射酮咯酸与对乙酰氨基酚对减少鼻整形术患者术后疼痛的效果:双盲随机临床试验

Effect of a Single Preventive Intravenous Dose of Ketorolac and Paracetamol on Reducing Postoperative Pain in Septorhinoplasty Patients: Double-Blind Randomized Clinical Trial.

作者信息

Dehghanpisheh Laleh, Jamshidi Fatane, Khademi Saeid, Farokhiani Shirin, Cheraghi Mohammad Reza, Emadi Mahsa, Kaboodkhani Reza, Akbari Ali, Asmarian Naeimehossadat, Banifatemi Mahsa

机构信息

Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Iran J Med Sci. 2025 Apr 1;50(4):239-246. doi: 10.30476/ijms.2024.102131.3488. eCollection 2025 Apr.

DOI:10.30476/ijms.2024.102131.3488
PMID:40255229
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12008656/
Abstract

BACKGROUND

Effective pain management is crucial in septorhinoplasty and remains a significant challenge. This study investigated the effect of ketorolac and paracetamol on pain control in septorhinoplasty patients and assessed their efficacy in reducing the need for rescue analgesics.

METHODS

This double-blind randomized clinical trial was conducted at Madar-Koodak Hospital (Shiraz, Iran), in 2022. Ninety-nine patients were randomly assigned to three groups to receive ketorolac 30 mg (n=33), paracetamol 1000 mg (n=33), and normal saline (n=33), respectively. All the medications were administered intravenously (IV) 30 min before surgery. The randomization procedure followed the block randomization method. If the pain did not subside, patients were also given a single dose of pethidine hydrochloride (25 mg). Pain intensity was measured using visual analog scale (VAS) 1 hour and 6 hours after surgery. The data were analyzed using SPSS software, using paired tests, ANOVA, and Chi square tests.

RESULTS

One-hour post-surgery, VAS scores in the ketorolac and paracetamol groups were significantly lower than in the placebo group (P<0.001). The mean difference with 95% CI for ketorolac-placebo and paracetamol-placebo was -0.57 (-0.94, -0.21), and -0.79 (-1.12, -0.45), respectively. The ketorolac and paracetamol groups required significantly less pethidine hydrochloride 1 hour post-surgery than the placebo group (P<0.001). The VAS scores and requiring pethidine were not significantly different between the ketorolac and paracetamol groups.

CONCLUSION

After septorhinoplasty, the administration of 1000 mg of IV paracetamol demonstrated comparable efficacy in pain reduction to 30 mg of ketorolac. It suggested that paracetamol could serve as a viable alternative to ketorolac in preventing postoperative pain after septorhinoplasty, particularly in patients for whom non-steroidal anti-inflammatory (NSAID) drugs could not be a suitable choice. IRCT20180922041084N6.

摘要

背景

有效的疼痛管理在鼻中隔成形术中至关重要,且仍然是一项重大挑战。本研究调查了酮咯酸和对乙酰氨基酚对鼻中隔成形术患者疼痛控制的影响,并评估了它们在减少急救镇痛药需求方面的疗效。

方法

这项双盲随机临床试验于2022年在伊朗设拉子的马达尔 - 库达克医院进行。99名患者被随机分为三组,分别接受30毫克酮咯酸(n = 33)、1000毫克对乙酰氨基酚(n = 33)和生理盐水(n = 33)。所有药物均在手术前30分钟静脉注射。随机化程序采用区组随机化方法。如果疼痛未缓解,患者还会给予单剂量盐酸哌替啶(25毫克)。术后1小时和6小时使用视觉模拟量表(VAS)测量疼痛强度。使用SPSS软件对数据进行分析,采用配对检验、方差分析和卡方检验。

结果

术后1小时,酮咯酸组和对乙酰氨基酚组的VAS评分显著低于安慰剂组(P < 0.001)。酮咯酸 - 安慰剂组和对乙酰氨基酚 - 安慰剂组的95%置信区间的平均差异分别为 -0.57(-0.94,-0.21)和 -0.79(-1.12,-0.45)。术后1小时,酮咯酸组和对乙酰氨基酚组所需的盐酸哌替啶明显少于安慰剂组(P < 0.001)。酮咯酸组和对乙酰氨基酚组之间的VAS评分和所需哌替啶无显著差异。

结论

鼻中隔成形术后,静脉注射1000毫克对乙酰氨基酚在减轻疼痛方面显示出与30毫克酮咯酸相当的疗效。这表明对乙酰氨基酚在预防鼻中隔成形术后疼痛方面可作为酮咯酸的可行替代药物,特别是对于非甾体抗炎药不是合适选择的患者。IRCT20180922041084N6。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b55e/12008656/ced70a6c191a/IJMS-50-239-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b55e/12008656/ced70a6c191a/IJMS-50-239-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b55e/12008656/ced70a6c191a/IJMS-50-239-g001.jpg

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本文引用的文献

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A comparative study of the analgesic effects of intravenous ketorolac, paracetamol, and morphine in patients undergoing video-assisted thoracoscopic surgery: A double-blind, active-controlled, randomized clinical trial.静脉注射酮咯酸、对乙酰氨基酚和吗啡在接受电视辅助胸腔镜手术患者中的镇痛效果比较:一项双盲、主动对照、随机临床试验。
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