Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults

 

Abstract

Background

Naproxen, a non-steroidal anti-inflammatory drug, is used to treat various painful conditions including postoperative pain, and is often administered as the sodium salt to improve its solubility. This review updates a 2004 Cochrane review showing that naproxen sodium 550 mg (equivalent to naproxen 500 mg) was effective for treating postoperative pain. New studies have since been published.

Objectives

To assess efficacy, duration of action, and associated adverse events of single dose oral naproxen or naproxen sodium in acute postoperative pain in adults.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to October 2008.

Selection criteria

Randomised, double blind, placebo-controlled trials of single dose orally administered naproxen or naproxen sodium 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 four to six 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

The original review included 10 studies with 996 participants. This updated review included 15 studies (1509 participants); 11 assessed naproxen sodium and four naproxen. In nine studies (784 participants) using 500/550 mg naproxen or naproxen sodium the NNT for at least 50% pain relief over four to six hours was 2.7 (95% CI 2.3 to 3.2). No dose response was demonstrated over the range 200/220 mg to 500/550 mg, but limited data was identified. Median time to use of rescue medication was 8.9 hours for naproxen 500/550 mg and 2.0 hours for placebo. Use of rescue medication was significantly less common with naproxen than placebo. Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal.

Authors' conclusions

Doses equivalent to 500 mg and 400 mg naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain. About half of participants treated with these doses experienced clinically useful levels of pain relief, compared to 15% with placebo, and half required additional medication within nine hours, compared to two hours with placebo. Associated adverse events did not differ from placebo.

 

Plain language summary

Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults

This review assessed evidence from 1509 participants in 15 randomised, double blind, placebo-controlled clinical trials of naproxen or naproxen sodium (a non-steroidal anti-inflammatory drug) in adults with moderate to severe acute postoperative pain. At doses equivalent to 500 mg and 400 mg, orally administered naproxen provides effective analgesia. About half of those treated experienced at least half pain relief over four to six hours, and the effects lasted, on average, up to nine hours. Associated adverse events did not differ from placebo, but these studies are of limited use for studying adverse effects.

 

摘要

背景

使用單一劑量口服naproxen和naproxen sodium 治療手術後急性疼痛

術後疼痛往往有控制不佳的情形。治療方式包括一系列的藥物療法，諸如非類固醇抗發炎藥物(nonsteroidal antiinflammatory drugs ；NSAIDs)，naproxen就是其中之一。naproxen常被用來治療各種疼痛，其中包括術後的急性疼痛，它常常被製為鈉鹽製劑，以改善口服給藥後的溶解度。Naproxen sodium 550毫克(相當於500毫克Naproxen)被認為是一個治療術後疼痛的有效劑量，但至今在已發表的文獻中，還沒有有系統的探討naproxen/naproxen sodium在不同劑量的成效。

目標

以評估單劑量口服naproxen 或naproxen sodium 治療成年病患在術後急性疼痛的療效、安全性和藥效持續的作用時間。

搜尋策略

我們搜尋了The Cochrane Library, MEDLINE, EMBASE 和 the Oxford Pain Relief Database資料庫中的相關研究。額外的研究是從已確定的參考清單所摘錄出來。最近期的檢索是在2004年7月。

選擇標準

我們收納了使用單劑量口服naproxen 或 naproxen sodium 治療術後急性疼痛的成年病患。收案方式是採隨機、雙盲且有安慰劑對照的試驗方式收案。

資料收集與分析

擷取疼痛緩解或疼痛強度的數據，轉化為二分訊息，計算至少50 ％疼痛緩解且超過4至6小時的病患數目，相對危險比值(RR)和多少需要到治療(NNT)。收集有副作用經驗的人數和比例，以計算有多少需要到傷害(NNH)。同時估算需要多少時間需要再次給予藥物治療。

主要結論

10項試驗(996位病患)符合納入收案標準：9項試驗是有關 naproxen sodium的探討;其中1項試驗是合併兩個小型針對單獨使用naproxen評估後的結果。我們將這些收納的研究以方法學加以量化。統合分析(Metaanalysis)6項研究(500位病患)，naproxen sodium 550毫克與安慰劑組相比，至少得到50 ％的疼痛緩解且超過4至6個小時的相對危險性為4.2 (95 ％CI 2.9至6.0)和多少需要治療為2.6 95 ％CI 2.2至3.2)。有3項試驗(334位病患)評估naproxen 400毫克和naproxen sodium 440毫克，得到相對危險性為4.8(95 ％CI 2.75 至8.38)。有兩個小的研究指出，naproxen 200毫克和naproxen sodium 220毫克，可提供有效的術後止痛。此藥物的副作用方面與安慰劑相比無顯著之統計差異。加權再次給藥均值的時間naproxen sodium 550毫克為7.6小時，安慰劑則為2.6小時。

作者結論

不論口服Naproxen sodium 550毫克、naproxen 400毫克或naproxen sodium 440毫克對手術後急性疼痛的成年病患都具有效的止痛效果。只有一個低發生率的副作用被發現，但對此副作用的報告並不一致。

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

Naproxen sodium 對手術後急性疼痛的成年病患的止痛是有效的。手術後急性疼痛是一個立即性的問題，可能會有控制不佳的情形。此篇評論是綜合10個隨機、雙盲且安慰劑對照的臨床試驗的結果，其針對996位手術急性疼痛的成人病患口服給予naproxen/naproxen sodium(非類固醇抗發炎藥物)的評估。我們發現在手術後口服naproxen sodium 550毫克和440毫克是有效扼殺術後疼痛的方式。平均一次口服藥效可維持七個小時以上。因為副作用的報告都不一致，所以對naproxen 和 naproxen sodium 的副作用目前仍無定論。