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盐酸羟考酮与芬太尼用于全髋关节置换术后疼痛的有效性和安全性比较:一项随机三盲试验

Comparison of Effectiveness and Safety of Oxycodone Hydrochloride and Fentanyl for Post-operative Pain Following Total Hip Arthroplasty: A Randomized Triple-Blind Trial.

作者信息

Kohaf Neveen, Harby Salama A, Abd-Ellatief Ahmed F, Elsaid Mohamed A, Abdelmottaleb Neazy A, Abd Elsalam Tamer F

机构信息

Lecturer of Clinical Pharmacy, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt.

Lecturer of Anesthesiology, Intensive Care and Pain Management, Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

出版信息

Anesth Pain Med. 2024 Feb 16;14(1):e142710. doi: 10.5812/aapm-142710. eCollection 2024 Feb.

Abstract

BACKGROUND

Total hip replacement (THR) is frequently associated with intense post-surgical pain. Effective pain management is of crucial importance to improving patient's condition and increasing his/her satisfaction in the post-operative time.

OBJECTIVES

This study aimed to compare the analgesic effect and safety of oxycodone and fentanyl after THR.

METHODS

Seventy-two cases scheduled for elective THR were included in this randomized, triple-blind trial. The patients were equally randomized into 2 groups: Fentanyl group (50 ug of fentanyl) and oxycodone group (oxycodone 4 mg). Drugs were received 20 min prior to the end of the operation.

RESULTS

Post-operative visual analog scale (VAS) measurements at rest and movement at the post-anesthesia care unit (PACU) and in the ward, 2 h, 4 h, and 8 h post-operatively exhibited a significantly reduced value in the oxycodone group compared to the fentanyl group (P-value < 0.05). Time to first rescue for analgesia was delayed significantly in the oxycodone compared to the fentanyl group (P-value < 0.001). Fentanyl consumption (ug) in the 1st post-operative 12 h, 24 h, and 48 h decreased significantly in the oxycodone group compared to the fentanyl group (P-value < 0.001). Post-operative nausea, vomiting, headache, and pruritus were matched between the 2 groups (P > 0.05).

CONCLUSIONS

A bolus dose of 4 mg of oxycodone provided superior analgesic efficacy than 50 ug fentanyl as evidenced by significantly lower pain score, delayed onset to first request for analgesia, and the smaller amount of fentanyl consumption at 12, 24, and 48 h post-total hip arthroplasty compared to fentanyl. The incidence of adverse events was comparable between the 2 groups.

摘要

背景

全髋关节置换术(THR)术后常伴有剧烈疼痛。有效的疼痛管理对于改善患者状况及提高其术后满意度至关重要。

目的

本研究旨在比较全髋关节置换术后羟考酮和芬太尼的镇痛效果及安全性。

方法

本随机、三盲试验纳入72例行择期全髋关节置换术的患者。患者被随机分为两组:芬太尼组(50μg芬太尼)和羟考酮组(4mg羟考酮)。在手术结束前20分钟给药。

结果

与芬太尼组相比,术后在麻醉后恢复室(PACU)及病房静息和活动时,术后2小时、4小时及8小时的视觉模拟评分(VAS)测量显示羟考酮组数值显著降低(P值<0.05)。与芬太尼组相比,羟考酮组首次镇痛补救时间显著延迟(P值<0.001)。与芬太尼组相比,羟考酮组术后12小时、24小时及48小时的芬太尼消耗量(μg)显著降低(P值<0.001)。两组术后恶心、呕吐、头痛及瘙痒情况相当(P>0.05)。

结论

与芬太尼相比,4mg羟考酮推注剂量在全髋关节置换术后疼痛评分显著更低、首次镇痛请求时间延迟以及12、24和48小时芬太尼消耗量更小,显示出比50μg芬太尼更优的镇痛效果。两组不良事件发生率相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73a5/11078234/bcb6952a6a88/aapm-14-1-142710-i001.jpg

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