Topical agents or dressings for pain in venous leg ulcers.

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 STRATEGY: 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), I(2) = 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.