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Meta-Analysis
. 2012 Nov 14;11(11):CD001177.
doi: 10.1002/14651858.CD001177.pub3.

Topical agents or dressings for pain in venous leg ulcers

Michelle Briggs  1 , E Andrea Nelson, Marrissa Martyn-St James
Affiliations
Meta-Analysis

Topical agents or dressings for pain in venous leg ulcers

Michelle Briggs et al. Cochrane Database Syst Rev. .

Abstract

Background: Venous leg ulcers affect up to 1% of people at some time in their lives and are often painful. The main treatments are compression bandages and dressings. Topical treatments to reduce pain during and between dressing changes are sometimes used.

Objectives: To determine the effects of topical agents or dressings for pain in venous leg ulcers.

Search methods: For this third update the following databases were searched: Cochrane Wounds Group Specialised Register (searched 9 May 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 4); Ovid MEDLINE (2009 to April Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations May 08, 2012); Ovid EMBASE (2009 to 2012 Week 18); and EBSCO CINAHL (2009 to May 2 2012). No date or language restrictions were applied.

Selection criteria: Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of topical agents or dressing for the treatment of pain in venous ulcers were included.

Data collection and analysis: Two review authors independently performed trial selection, data extraction and risk of bias assessment.

Main results: Six trials (343 participants) evaluated Eutectic Mixture of Local Anaesthetics (EMLA): lidocaine-prilocaine cream for the pain associated with ulcer debridement. The between-group difference in pain measured on a 100 mm scale was statistically significant in favour of EMLA (MD -20.65, 95% CI -12.19 to -29.11). No significant between-group differences in burning or itching were observed.Two trials (470 participants with venous leg ulcers) evaluated ibuprofen slow-release foam dressings for persistent venous leg ulcer pain. Compared with local best practice, significantly more participants in the ibuprofen dressing group achieved the outcome of >50% of the total maximum pain relief score between day 1 and day 5 than participants in the local best practice group (RR 1.63, 95% CI 1.24 to 2.15). The number needed to treat was 6 (95% CI 4 to 12). In the second trial, compared with an identical non-ibuprofen foam dressing, there was no statistically significant difference in the proportion of participants experiencing slight to complete pain relief on the first evening of treatment.Limited data were available to assess healing rates or adverse events.

Authors' conclusions: There is some evidence to suggest that ibuprofen dressings may offer pain relief to people with painful venous leg ulcers. EMLA (5%) appears to provide effective pain relief during the debridement of venous leg ulcers. Further research should consider standardised pain assessment methods and assess both the effect on ulcer healing and the impact of long term use of these treatments.

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Conflict of interest statement

A research award made by the European Wound Management Association (a registered UK Charity, number 1042404) which included funds from Seton Scholl Healthcare (who manufacture wound dressings) partly funded this review. However, this review was conducted independently of the charity and of Seton Scholl Healthcare. Seton Scholl Healthcare do not manufacture any of the products included in the review. The Smith and Nephew Foundation funded the update of the review. The review was carried out independently and Smith and Nephew do not manufacture any products featured within the review.

Marrissa Martyn‐St James receives funding from the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP‐PG‐0407‐10428). The views expressed in this review are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Figures

1
1
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.
1.1
1.1. Analysis
Comparison 1 EMLA compared with placebo or no anaesthesia, Outcome 1 Pain score at debridement.
1.2
1.2. Analysis
Comparison 1 EMLA compared with placebo or no anaesthesia, Outcome 2 Number of healed wounds.
1.3
1.3. Analysis
Comparison 1 EMLA compared with placebo or no anaesthesia, Outcome 3 Incidence of burning at removal of cream.
1.4
1.4. Analysis
Comparison 1 EMLA compared with placebo or no anaesthesia, Outcome 4 Incidence of itching at removal of cream.
2.1
2.1. Analysis
Comparison 2 Ibuprofen foam dressing compared with foam dressing alone, Outcome 1 Number participants experiencing pain relief on the first evening of treatment.
2.2
2.2. Analysis
Comparison 2 Ibuprofen foam dressing compared with foam dressing alone, Outcome 2 Number of healed wounds.
2.3
2.3. Analysis
Comparison 2 Ibuprofen foam dressing compared with foam dressing alone, Outcome 3 Number participants experiencing adverse events.
3.1
3.1. Analysis
Comparison 3 Ibuprofen foam dressing compared with local best practice, Outcome 1 Number participants reporting TOTPARD5>50%.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Allen 1982 {published data only}
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Sibbald 2011 {published data only}
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Stacey 1999 {published data only}
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References to studies awaiting assessment

Claeys 2011 {published data only}
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