Topical agents or dressings for pain in venous leg ulcers

 

Abstract

Background

Venous leg ulcers affect up to 1 per cent of people at some time in their lives. The main treatments are compression bandages and dressings. As these ulcers are often painful some clinicians choose particular dressings and topical treatments (analgesia/ local anaesthetic) to reduce the pain both during and between dressing changes.

Objectives

To assess the effectiveness of dressings, local anaesthetics or topical analgesia for pain relief in venous leg ulceration.

Search methods

For this update the search strings were revised and the following databases were searched: The Cochrane Wounds Group Specialised Register (Searched 16/12/09) The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library Issue 4 2009; Ovid MEDLINE - 1950 to November Week 3 2009; Ovid EMBASE - 1980 to 2009 Week 50; EBSCO CINAHL - 1982 to December 16 2009. No date or language restrictions were applied.

Selection criteria

Randomised controlled trials which evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement. Ulcer healing and reported adverse events were also considered as further outcomes.

Data collection and analysis

Eligibility for inclusion was confirmed by two review authors who independently assessed the potential trials.

Main results

Two trials evaluating interventions for persistent venous leg ulcer pain were identified for this review update. Both studies evaluated ibuprofen slow release foam dressings; one comparing it with local best practice and the other with an identical foam comparator. The primary end point for both studies was "pain relief achieved". When compared with a foam dressing alone, there was no evidence of a statistically significant effect of the ibuprofen foam dressing in terms of achieving some pain relief the first evening after treatment: 74% in the ibuprofen group (46/62) had pain relief compared with 58% (35/60) in the foam group (no significant difference: RR 1.27, 95%CI 0.98 to 1.65). In the second study 100% (32/32) of people with venous ulcers achieved some pain relief with the ibuprofen dressing on the first evening of treatment compared with 93% (26/28) in the local best practice group (no significant difference: RR 1.08, 95% CI 0.96 to 1.21). Pooling these studies in a meta-analysis (using a random effects model as significant heterogeneity present (p=0.1), I² = 64%) there is no evidence that ibuprofen dressings increase the pain relief experienced by the first evening of use (RR 1.15, 95% CI 0.91 to 1.44). We were not able to extract sufficient data to combine other pain outcomes from these trials. There was no difference in healing rates but slightly more adverse events with ibuprofen dressings than with a similar foam dressing without ibuprofen.

Six trials evaluated interventions for the pain associated with debridement and were considered sufficiently similar to pool. There was a statistically significant reduction in debridement pain scores with 5% Eutectic Mixture of Local Anaesthetics (EMLA): lidocaine-prilocaine cream; the difference in means (measured on a 100 mm scale) was 20.6 mm (95% CI 12.19 to 29.11). Of these six trials, only one small trial measured healing as an outcome and found no difference in the numbers of ulcers healed at the end of the study.

Authors' conclusions

There is no evidence that ibuprofen dressings offer pain relief, as measured at the first evening of use, to people with painful venous leg ulcers compared with foam dressings or best practice.

EMLA appears to provide effective pain relief for venous leg ulcer debridement but the effect (if any) of EMLA on ulcer healing remains unknown.

 

Plain language summary

Topical agents or dressings for reducing pain in venous leg ulcers

Venous leg ulcers are often painful, both during and between dressing changes, and during surgical removal of dead tissue (debridement). Dressings, topical creams and lotions have been promoted to reduce the pain of ulcers. Two trials tested a dressing containing ibuprofen and found no significant difference in the chance of pain relief measured on the first night of treatment, for ibuprofen dressings compared with foam or best practice. However these studies were small and patients were only followed for a few weeks which may not be long enough to assess whether the dressing affects healing. There was good evidence from 6 trials that a local anaesthetic cream (EMLA) reduces the pain of debriding leg ulcers but there was insufficient evidence of the impact of this cream on side effects and on healing.

 

摘要

背景

外用藥物或敷料用於下肢靜脈潰瘍 (venous leg ulcers) 疼痛

下肢靜脈潰瘍影響多達百分之一的人，在其生活中的一段時間。主要治療方法為壓縮繃帶和敷料。由於這些潰瘍常是疼痛的，有些臨床醫生選擇特定敷料和外用治療 (鎮痛劑/局部麻醉劑) 以減輕換藥時和換藥間的疼痛。

目標

評估敷料、局部麻醉劑或外用鎮痛劑用於減輕靜脈下肢潰瘍疼痛的療效。

搜尋策略

為此次更新搜尋字串經過修改，並以下列資料庫進行搜尋: The Cochrane Wounds Group Specialised Register (Searched 16/12/09) The Cochrane Central Register of Controlled Trials (CENTRAL)  The Cochrane Library Issue 4 2009; Ovid MEDLINE  1950 to November Week 3 2009; Ovid EMBASE1980 to 2009 Week 50; EBSCO CINAHL −1982 to December 16 2009。未現制日期與語言。

選擇標準

以評估用於減輕靜脈下肢潰瘍疼痛之局部介入的隨機對照組試驗做為考量。疼痛定義為持續性疼痛或更換敷料或清理傷口時的疼痛。潰瘍的瘉合及不良事件的通報亦被視為進一步成果。

資料收集與分析

納入的合格性經由兩位審閱者獨立評估潛在的試驗。

主要結論

此次回顧更新確認兩個評估針對持續性靜脈下肢潰瘍疼痛的介入。兩項試驗評估ibuprofen slow 緩釋泡沫敷料; 一試驗為與局部最佳操作比較以及另一為相較於相同的泡沫比較劑。兩項研究的主要結果為「達到疼痛減緩」。當與泡沫敷料單獨比較，未有證據顯示ibuprofen 泡沫敷料於第一睌治療後表現出某些疼痛減緩上具有統計上顯著的效果: 74% 的ibuprofen組 (46/62) 有疼痛減緩，相較於58% (35/60) 的泡沫組 (沒有顯著差異: 相對風險值RR 1.27, 95% 信心範圍CI 0.98 to 1.65) 。第二個研究中100% (32/32) 靜脈潰瘍的人第一晚以ibuprofen敷料治療呈現一些疼痛的減緩，相較於93% (26/28) 的接受局部最佳操作未有顯著的差異 (相對風險值RR 1.27, 95% 信心範圍 CI 0.98 to 1.65) 。 合併這些研究於統合分析 (使用隨機效果模型現住的異質性呈現 (p = 0.1), I2 = 64%) 沒有證據顯示ibuprofen敷料於使用的第一晚增加疼痛減緩的經驗 (RR 1.15, 95% CI 0.91 to 1.44) 。我們無法自這些試驗結合其他成果擷取足夠數據。使用ibuprofen敷料與否之間沒差別，但相較於相似泡沫敷料有稍微較多的不良事件。六個試驗評估清創有關的疼痛介入被視為有充分相似足以合併。使用局部麻醉劑5% Eutectic Mixture of Local Anaesthetics (EMLA) 統計上明顯降低清創疼痛的分數: lidocaineprilocaine cream;以100 mm量尺測量的平均差為20.6毫米 (95% 信心範圍 12.19 to 29.11) 。六個試驗中僅有一個小試驗量測癒合作為成果，並發現研究結束時癒合的潰瘍數未有差異。 (以下原來的文字不知出自何處1999年和2002年的初始回顧整理中，並沒有發現評估持續性疼痛治療之試驗。1999年回顧整理包含三個試驗，比較共熔混合物局部麻醉劑 (eutectic mixture of local anaesthetic (EMLA)) 和安慰劑，治療清潔傷口時的疼痛。2002年新增三個試驗 (總共六個試驗，317位受試者) 。這些研究夠相似，故可以合併做後設分析 (meta analysis) 。分析結果顯示：使用EMLA5% 乳霜清潔傷口，疼痛指數的降低是有統計顯著性的。EMLA和疼痛指數降低20.6公釐 (95% 信賴區間(Confidence Interval)29.11 – 12.19) 是有相關的 (以100公釐指數表測量). 一個小型試驗將復原狀態列入試驗結果。發現試驗結束後，潰瘍復原數沒有差別)

作者結論

相較於泡沫敷料或最佳操作，沒有證據顯示使用ibuprofen 敷料第一晚可減緩疼痛的靜脈下肢潰瘍的疼痛。EMLA顯然有效減輕靜脈性下肢潰瘍傷口清創時的疼痛。但EMLA於潰瘍癒合的效果仍未清清楚。

翻譯人

本摘要由成功大學附設醫院尹子真翻譯。

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

總結

外用藥物或敷料用於下肢靜脈潰瘍疼痛。下肢靜脈潰瘍常疼痛於更換敷料的當時或在間隔時間，以及手術除去換死組織 (清創) 的時候。敷料、外用乳霜或乳液有助於促進潰瘍疼痛的減少。兩項試驗測試含有ibuprofen 的敷料，相較於泡沫或最佳處置措施，發現使用的第一晚治療對於減輕疼痛沒有明顯差異。然而這些研究屬於小型且病患緊追蹤數週，可能時間尚不足以評估是否敷料影響愈合的情況。有六個試驗顯示局部麻醉乳霜降低清創腿部時的疼痛有良好的證據。但沒有足夠證據顯示這項乳霜對於副作用以及癒合的影響。