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昂丹司琼对急性阑尾炎手术后疼痛和呕吐的影响:一项安慰剂对照双盲随机临床试验。

Effect of Ondansetron on Postoperative Pain and Vomiting after Acute Appendicitis Surgery: A Placebo-Controlled Double-Blinded Randomized Clinical Trial.

机构信息

Department of Orthopedic Surgery, Joint Reconstruction Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Surgical Research Society (SRS), Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Pain Res Manag. 2024 Jun 12;2024:6429874. doi: 10.1155/2024/6429874. eCollection 2024.

Abstract

BACKGROUND

Common postoperative complications following surgery, particularly acute appendicitis surgery, include postoperative pain and vomiting, which can cause discomfort and delay recovery time.

METHODS

A randomized double-blinded placebo-controlled clinical trial was conducted with 80 cases of acute appendicitis of American Society of Anesthesiologists (ASA) physical status I or II and aged 18-60 y/o scheduled for appendectomy under general anesthesia. Patients were randomly divided into two equal groups: group A received 4 mg of ondansetron IV (2 ml) and group B received 2 ml of normal slain IV (placebo). Pain according to VAS, nausea and vomiting according to clinical symptoms, shivering and sedation according to the Bedside Shivering Assessment Scale (BSAS), and the Ramsay Sedation Scale (RSS) at 2, 6, 12, and 24 hours after surgery were evaluated and compared between the groups.

RESULTS

There was a significant decline in the severity of pain only at 2 hours after surgery between the ondansetron and control groups (5.3 ± 1.0 vs. 6.0 ± 1.0; =0.01), not showing a difference between the groups at 6, 12, and 24 hours after appendectomy. Postoperative nausea and vomiting at 2 (5% vs. 25%; =0.03) and 6 (7.5% vs. 27.5%; =0.04) hours after appendectomy in the ondansetron group. At different times, the ondansetron and control groups did not differ in terms of pethidine consumption or sedation.

CONCLUSIONS

In conclusion, our study found that ondansetron was effective in reducing postoperative vomiting after acute appendicitis surgery. However, it did not show a clinically significant effect on postoperative pain. This trial is registered with IRCT20230722058883N1.

摘要

背景

手术后常见的并发症,特别是急性阑尾炎手术后,包括术后疼痛和呕吐,这可能会引起不适并延长恢复时间。

方法

采用随机、双盲、安慰剂对照的临床试验,纳入 80 例美国麻醉医师协会(ASA)身体状况 I 或 II 级、年龄在 18-60 岁之间的拟行全身麻醉下阑尾切除术的急性阑尾炎患者。患者随机分为两组,每组 40 例:A 组给予 4mg 昂丹司琼静脉注射(2ml),B 组给予 2ml 生理盐水静脉注射(安慰剂)。术后 2、6、12 和 24 小时,根据视觉模拟评分(VAS)评估疼痛、根据临床症状评估恶心和呕吐、根据床边寒战评估量表(BSAS)评估寒战、根据 Ramsay 镇静评分(RSS)评估镇静,并比较两组之间的差异。

结果

仅在术后 2 小时时,昂丹司琼组和对照组之间疼痛的严重程度有显著下降(5.3±1.0 vs. 6.0±1.0;=0.01),但在阑尾切除术后 6、12 和 24 小时时两组之间无差异。术后 2 小时(5% vs. 25%;=0.03)和 6 小时(7.5% vs. 27.5%;=0.04)时,昂丹司琼组恶心和呕吐的发生率较低。在不同时间点,昂丹司琼组和对照组在哌替啶消耗或镇静方面没有差异。

结论

总之,我们的研究发现昂丹司琼可有效减少急性阑尾炎手术后的术后呕吐,但对术后疼痛没有明显的临床效果。本试验已在 IRCT20230722058883N1 注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09fe/11186684/8f16c62ec92f/PRM2024-6429874.001.jpg

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