Single dose oral diclofenac for acute postoperative pain in adults

 

Abstract

Background

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), available as a potassium salt (immediate-release) or sodium salt (delayed-release). This review updates an earlier review published in The Cochrane Database of Systematic Reviews (Issue 2, 2004) on 'Single dose oral diclofenac for postoperative pain'.

Objectives

To assess single dose oral diclofenac for the treatment of acute postoperative pain.

Search methods

Cochrane CENTRAL, MEDLINE, EMBASE, Biological Abstracts, the Oxford Pain Relief Database, and reference lists of articles were searched; last search December 2008.

Selection criteria

Randomised, double-blind, placebo-controlled clinical trials of single dose, oral diclofenac (sodium or potassium) for acute postoperative pain in adults.

Data collection and analysis

Two review authors independently assessed studies for inclusion and quality, and extracted data. The area under the pain relief versus time curve was used to derive the proportion of participants with at least 50% pain relief over 4 to 6 hours, using validated equations. Relative benefit (risk) and number needed to treat to benefit (NNT) were calculated. Information on adverse events, time to remedication, and participants needing additional analgesia was also collected.

Main results

Fifteen studies (eight additional studies) with 1512 participants more than doubled the information available at each dose. Overall 50% to 60% of participants experienced at least 50% pain relief over 4 to 6 hours at any dose with diclofenac, compared to 10 to 20% with placebo, giving NNTs of about 2.5 for doses of 25 mg to 100 mg (similar to earlier review); no dose response was demonstrated. At 50 mg and 100 mg, NNTs for diclofenac potassium (2.1 (1.8 to 2.4) and 1.9 (1.7 to 2.2)) were significantly lower (better) than for diclofenac sodium (6.7 (4.2 to 17) and 4.5 (3.2 to 7.7)). The median time to use of rescue medication was 2 hours for placebo, 4.3 hours for diclofenac 50 mg and 4.9 hours for diclofenac 100 mg. Adverse events were reported at a similar rate to placebo, with no serious events.

Authors' conclusions

Oral diclofenac is an effective single-dose treatment for moderate to severe postoperative pain. Significantly more participants experienced at least 50% pain relief over 4 to 6 hours with diclofenac potassium than with diclofenac sodium. There was no significant difference between diclofenac and placebo in the incidence of adverse events.

 

Plain language summary

Single dose oral diclofenac for pain relief in adults experiencing moderate or severe pain following a surgical procedure

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pain relieving properties. It is used to treat many painful conditions, including acute postoperative pain. This review shows that single dose oral diclofenac provides effective pain relief for adults experiencing moderate or severe pain following a surgical procedure. For every five participants with moderate to severe postoperative pain treated with a single dose of diclofenac, two would experience at least 50% pain relief who would not have done so with placebo. One form of diclofenac, the potassium salt, is more effective at the same dose than the other form of diclofenac, the sodium salt. The incidence of adverse effects did not differ significantly from placebo in these single dose studies.

 

摘要

背景

使用單一劑量口服diclofenac 治療手術後疼痛

Diclofenac 是一種非固醇抗發炎止痛藥(NSAIDs)，可用的劑型為鉀鹽(立即釋放)或鈉鹽(延遲釋放)。本篇評論是更新上ㄧ次的Cochrane的系統整合資料(２００４年，議題２)：使用單一劑量口服diclofenac 治療手術後疼痛。

目標

評估單劑量口服Diclofenac治療急性術後疼痛之療效，並探討不同的製劑之間的差異。

搜尋策略

我們搜尋了Cochrane Library(Issue 2, 2003)，MEDLINE(1966年至1966年5月)，EMBASE(1980年至1996年)，Biological Abstracts(1985年至2003年)，the Oxford pain database(1950年至1994年)，PubMed(1996年至2003年)等資料庫和參考資料表列的文獻。

選擇標準

我們收納了使用單劑量口服Diclofenac治療術後急性疼痛的成年病患。收案方式是採隨機雙盲且安慰劑對照的臨床試驗，且Diclofenac再分為鈉鹽與鉀鹽兩種製劑分別收案。

資料收集與分析

我們收納了兩個獨立審查的作者所評論的試驗，檢選數據與進行質性分析。以疼痛緩解隨時間改變曲線下的面積計算的病患使用diclofenac或安慰劑後至少疼痛緩解50 ％超過4至6小時的比例；並計算有多少需要治療的分數(NNT)，同時也收集副作用的資料。

主要結論

一個額外的試驗被收納加入原有的六個原著的試驗。所以共有七個試驗納入質量分析：581位患者接受diclofenac治療，另有364位患者接受安慰劑治療。使用25毫克、50毫克和100毫克之diclofenac與安慰劑相比)，其需要治療的分數分別為2.8(95 ％CI 2.1 至4.3)， 2.3(95 ％CI 2.0 至2.7)和 1.9(95 ％CI 1.6 至2.2)。雖然高劑量比低劑量有較低之NNT值(效果較好)，但是在統計上並無顯著差異。在病患服藥後產生頭暈、頭疼、噁心和嘔吐的經驗上，接受50毫克diclofenac組與安慰劑組相比，並無顯著統計差異。時間加權計算中位數，安慰劑止痛為2小時，diclofenac 50毫克止痛為6.7小時，和diclofenac 100毫克止痛為7.2小時。進一步針對藥物的製劑型態、疼痛模式、試驗的規模和質量的敏感度分析，都沒有任何統計上的顯著差異。

作者結論

單劑量口服Diclofenac對中度至重度之急性術後疼痛之治療是有效的。不論與安慰劑相比之副怍用，或是鈉鹽和鋰鹽之間的不同製劑型態、不同的疼痛模式、試驗的規模大小和質量上之分析皆無明顯之統計差異。

翻譯人

本摘要由三軍總醫院謝凱芝翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

單劑量口服diclofenac對經歷中度或重度疼痛的外科手術疼痛的成年病患，提供了有效的疼痛緩解。diclofenac是一種非類固醇抗發炎藥物，其具有止痛的特性。在許多情況都可以使用diclofenac治療，手術後的急性疼痛就是其中一種。本篇評論所呈現的是單劑量口服diclofenac對經歷中度或重度疼痛的外科手術疼痛的成年病患，提供了有效的疼痛緩解。透過新數據的分析，diclofenac 鈉鹽和鋰鹽不同製劑之間的的作用並無差異。在副作用方面與安慰劑相比，亦無顯著差異。