Single dose oral ibuprofen for acute postoperative pain in adults

 

Abstract

Background

This review updates a 1999 Cochrane review showing that ibuprofen at various doses was effective in postoperative pain in single dose studies designed to demonstrate analgesic efficacy. New studies have since been published. Ibuprofen is one of the most widely used non-steroidal anti-inflammatory (NSAID) analgesics both by prescription and as an over-the-counter medicine. Ibuprofen is used for acute and chronic painful conditions.

Objectives

To assess analgesic efficacy of ibuprofen in single oral doses for moderate and severe postoperative pain in adults.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to May 2009.

Selection criteria

Randomised, double blind, placebo-controlled trials of single dose orally administered ibuprofen (any formulation) in adults with moderate to severe acute postoperative pain.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals were collected.

Main results

Seventy-two studies compared ibuprofen and placebo (9186 participants). Studies were predominantly of high reporting quality, and the bulk of the information concerned ibuprofen 200 mg and 400 mg. For at least 50% pain relief compared with placebo the NNT for ibuprofen 200 mg (2690 participants) was 2.7 (2.5 to 3.0) and for ibuprofen 400 mg (6475 participants) it was 2.5 (2.4 to 2.6). The proportion with at least 50% pain relief was 46% with 200 mg and 54% with 400 mg. Remedication within 6 hours was less frequent with higher doses, with 48% remedicating with 200 mg and 42% with 400 mg. The median time to remedication was 4.7 hours with 200 mg and 5.4 hours with 400 mg. Sensitivity analysis indicated that pain model and ibuprofen formulation may both affect the result, with dental impaction models and soluble ibuprofen salts producing better efficacy estimates. Adverse events were uncommon, and not different from placebo.

Authors' conclusions

The very substantial amount of high quality evidence demonstrates that ibuprofen is an effective analgesic in treating postoperative pain. NNTs for 200 mg and 400 mg ibuprofen did not change significantly from the previous review even when a substantial amount of new information was added. New information is provided on remedication.

 

Plain language summary

A single dose of ibuprofen administered orally to treat acute postoperative pain in adults

Ibuprofen at 200 mg and 400 mg produces a high level of pain relief in about half of those with moderate or severe acute postoperative pain. This is a good result compared with most other analgesics tested in a very well researched model of pain used for demonstrating that drugs can actually produce pain relief. There were no more adverse events than with placebo.

 

摘要

背景

單一劑量口服ibuprofen 作為成人手術後止痛

這次的回顧是更新1999年的Cochrane系統回顧，顯示研究的目的是想證明在不同劑量跟單一劑量的ibuprofen對術後疼痛的止痛效果是有效。新的研究已被發表。Ibuprofen是一種非類固醇消炎藥(NSAID)也是最廣泛使用的處方和櫃檯藥品止痛藥之一，用於急性和慢性疼痛的狀況。

目標

評估單一劑量口服ibuprofen 對成人手術後中度到重度疼痛的止痛效果。

搜尋策略

我們搜查Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database的研究，至2009年5月

選擇標準

單一劑量口服ibuprofen(任何形式)在成人中度至重度急性術後疼痛的隨機，雙盲，安慰劑對照試驗。

資料收集與分析

兩位獨立審查者評估列入審查試驗的品質並擷取數據。疼痛緩解或疼痛強度的數據擷取並轉換到受試者至少有50 ％的疼痛緩解4至6個小時的二分結果，而相對風險和numberneededtotreattobenefit (NNT)計算。受試者在超過規定的時間內使用救援鎮痛藥的人數，和使用救援止痛藥的時間點，被認為需要採取額外有效措施。不良反應事件的報告和撤回也被收集。

主要結論

有72項研究比較Ibuprofen和安慰劑(共有9186位受試者) 。研究報告的品質很高，而大部分的研究是關於Ibuprofen200毫克和400毫克。與安慰劑相比，至少50 ％的疼痛緩解的NNT在Ibuprofen200毫克(2690受試者)為2.7 (2.5 ～3.0)和在Ibuprofen400毫克(6475受試者)是2.5 (2.4 to 2.6)。至少50 ％的疼痛緩解在200毫克所佔比例為46%和在400毫克所佔比例為54%。 用高劑量的6小時內再次給藥是較少， 200毫克再次給藥是48%， 400毫克再次給藥是42%。 200毫克再次給藥的中位數時間是4.7小時而400毫克再次給藥的中位數時間是5.4小時，。敏感性分析顯示，疼痛模式和ibuprofen成分可能影響結果，用牙科壓緊模式和可溶性Ibuprofen估計可以產生更好的效果。副作用很少，和安慰劑組是一樣的。

作者結論

非常多數的高品質的證據顯示，Ibuprofen是一種有效的止痛藥用來治療手術後疼痛。即使增加大量的研究報告，Ibuprofen 在200毫克和400毫克的 NNTs和先前回顧相比也沒有明顯改變。新的報告提供再次給藥的訊息。

翻譯人

本摘要由三軍總醫院詹舜名翻譯。

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

總結

Ibuprofen在200毫克和400毫克有很好的止痛效果並緩解了大約一半的人中度或重度急性術後疼痛。與大多數其他在一個建構良好的研究模型的止痛測試來相比，顯示該藥物能夠真正產生疼痛緩解，這是一個很好的結果。跟安慰劑組相比目前還沒有更多的不良反應事件。