No influence of ibuprofen on bone healing after Colles’ fracture – A randomized controlled clinical trial

Abstract

IntroductionNonsteroidal anti-inflammatory drugs (NSAIDs) may delay bone healing. This knowledge is mainly derived from retrospective uncontrolled clinical studies and from animal experiments. The purpose of this prospective controlled study was to investigate whether ibuprofen influences pain, function, and bone healing after a Colles’ fracture. Patients and methodsA single center, triple-blind, randomized clinical trial. 95 patients, 80 females and 15 males, with displaced Colles’ fracture aged median 65 (range 40–85) years old were included and operated by external fixation from June 2012 through June 2015. 89 participants received interventional medicine and 83 completed the one-year follow-up. The 7-day ibuprofen group received 600 mg of ibuprofen three times a day, the 3-day ibuprofen group received ibuprofen for three days and a placebo for the following four days, and finally, the placebo group received a placebo for seven days. All patients received paracetamol 1000 mg four times a day and 50 mg tramadol if needed. The primary outcome were radiological changes in radius tilt, length, and inclination observed during and 6 weeks after the surgery. The analgesic outcome were 14 days experience of pain, and registered use of tramadol. The functional outcomes were the percentage differences in the motion between the injured and non-injured wrist, and the DASH score at 3 and 12 months. All analyses were performed according to the intention to treat. ResultsNo clinically relevant difference was observed in the radiological migration between the treatment groups, 0.064≤P ≤ 0.81. There was no difference in the pain score between the treatment groups, P = 0.13. The use of tramadol was lower in the ibuprofen groups than in the placebo group, P = 0.035. Ibuprofen treatment did not affect the range of motion, 0.148 ≤P ≤ 0.963. Patients in all groups demonstrated DASH score, and wrist motion improvement, close to 90% of normal amplitude. The complication rate was higher in the 7-day ibuprofen group compared to the placebo group, P = 0.043. ConclusionsIbuprofen treatment demonstrated a tramadol-sparing effect during the postoperative period. Neither wrist function nor radiological migration were influenced. The complication rate was higher in the ibuprofen-treated group compared the placebo-treated group.