Analgesic efficacy of an ibuprofenreleasing foam dressing compared with local best practice for painful exuding wounds

Abstract

To examine if wound aetiology has an effect on the pain-relieving properties of an ibuprofen-releasing foam dressing, which was previously shown to reduce pain in wounds of various aetiologies, compared with local best practice (LBP). This was a secondary analysis of data from a multicentre, randomised, parallel group trial of patients with painful exuding wounds of various aetiologies. Wound aetiology was determined at enrolment. Of 853 patients enrolled into the trial, 688 belonged to a wound aetiology subgroup that included >25 patients and were included in the analysis reported here. Patients were randomised to a dressing containing 112.5mg of ibuprofen (ibuprofen foam) or to LBP for 5 days. Patients recorded pain relief and pain intensity daily. The main endpoint was the proportion of patients who, from day 1 to day 5, reported a summed pain relief score >50% of the total maximum pain relief score (TOTPARD5>50%) and the corresponding number needed to treat (NNT) for each wound aetiology subgroup. Further analyses included the proportion of patients who, on a daily basis, reported pain relief >50% of the maximum daily pain relief, the proportion of patients who, on day 5, experienced a reduction in pain intensity of >50% of the maximum score (PIDD5>50%), and if PIDD5>50% was related to baseline pain intensity. Patients were categorised by the following five wound types: arterial, venous, and mixed arterial-venous leg ulcers, vasculitis and traumatic ulcers. The ibuprofen foam dressing was associated with significantly greater pain relief than LBP in all different wound aetiology subgroups, whether chronic or traumatic (acute). Overall, TOTPARD5>50% was 55% in the ibuprofen foam group and 24% in the LBP group (p<0.0001; NNT, 3.2). The pain intensity evaluations revealed similar results in favour of ibuprofen foam compared with LBP. No correlation was observed between PIDD5>50 and initial pain intensity. In this study, the ibuprofen foam dressing was shown to consistently relieve wound pain in exuding wounds of various aetiologies, irrespective of basal pain intensity. The data suggest that local pain relief by an ibuprofen foam dressing is possible in the most common, painful, exuding, chronic and acute/traumatic wounds and so is a safer alternative to systemic pain treatment.