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Randomized Controlled Trial
. 2007 Apr;4 Suppl 1(Suppl 1):24-34.
doi: 10.1111/j.1742-481X.2007.00312.x.

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers

Finn Gottrup  1 , Bo Jørgensen, Tonny Karlsmark, R Gary Sibbald, Rytis Rimdeika, Keith Harding, Patricia Price, Vanessa Venning, Peter Vowden, Michael Jünger, Stephan Wortmann, Rita Sulcaite, Gintaris Vilkevicius, Terttu-Liisa Ahokas, Karel Ettler, Monika Arenbergerova
Affiliations
Randomized Controlled Trial

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers

Finn Gottrup et al. Int Wound J. 2007 Apr.

Abstract

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicentre, randomised, double-blind clinical investigation of 122 patients compared two moist wound-healing dressings, a non adhesive foam dressing with ibuprofen (62 patients randomised to Biatain-Ibu non adhesive, Coloplast A/S) with a non adhesive foam without ibuprofen (60 to Biatain non adhesive). The ibuprofen-foam was regarded successful, if the pain relief on a 5-point verbal rating scale was higher than the comparator without compromising safety, including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 and days 43-47. The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group compared with the comparator on days 1-5, with a quick onset of action (P < 0.05). The patients in the ibuprofen-foam group had a significant (P < 0.05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%). Women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with increasing initial pain intensity and increasing wound size. Wound healing was similar in the ibuprofen-foam group to that of the comparator group. No difference in adverse events between placebo and local sustained release of low-dose ibuprofen was observed in this study. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters. The full report of this study will be published in Wound Repair and Regeneration.

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Conflict of interest statement

R. R. has acted as a paid researcher for Coloplast and received funding for that research. V. V. received funding for the salary of the research nurse involved in this work. P. V. and K. E. received renumeration for the extra time involved in study participation according to international guidelines. The authors are all members of the International Pain Advisory Board for Coloplast A/S and have been reimbursed for their services.

Figures

Figure 1
Figure 1
The patients were in two groups. On days 1–5 and on days 43–47, pain intensity was assessed on a numeric box scale and pain relief on a verbal rating scale.
Figure 2
Figure 2
Percentage of patients with pain relief the first evening including standard deviations. The first evening there were 28% more persons with pain relief in the ibuprofen – foam (74%) group, than the comparator group (58%).
Figure 3
Figure 3
Pain at dressing change on days 43–47 increased in the former ibuprofen–foam group (P = 0·05). NBS, numeric box scale.
Figure 4
Figure 4
Absolute change in ulcer area (cm2) on the intention‐to‐treat population. There was no statistical significant difference on ulcer area reduction (P = 0·26) between the treatment groups.
See this image and copyright information in PMC

References

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