Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): Randomised controlled trial

Marlene FRANSEN, Craig ANDERSON, Jan DOUGLAS, Stephen MACMAHON, Bruce NEAL, Robyn NORTON, Mark WOODWARD, Ian D. CAMERON, Ross CRAWFORD, Sing Kai LO, Garnet TREGONNING, Margaret WINDOLF

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Abstract

Objectives: To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
Design: Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
Setting: 20 orthopaedic surgery centres in Australia and New Zealand.
Participants: 902 patients undergoing elective primary or revision total hip replacement surgery.
Intervention: 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
Main outcome measures: Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
Results: There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
Conclusions: These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
Trial registration: NCT00145730 [ClinicalTrials.gov]. Copyright © 2006 BMJ Publishing Group Ltd.
Original languageEnglish
Pages (from-to)519-521
JournalBritish Medical Journal
Volume333
Issue number7567
DOIs
Publication statusPublished - 2006

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Ibuprofen
Postoperative Pain
Osteogenesis
Hip
Randomized Controlled Trials
Hip Replacement Arthroplasties
Safety
Placebos
Pain
Ontario
Non-Steroidal Anti-Inflammatory Agents
New Zealand
Reoperation
Arthritis
Orthopedics
Anti-Inflammatory Agents
Outcome Assessment (Health Care)
Confidence Intervals
Hemorrhage
Therapeutics

Citation

Fransen, M., Anderson, C., Douglas, J., MacMahon, S., Neal, B., Norton, R., . . . Windolf, M. (2006). Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): Randomised controlled trial. British Medical Journal, 333(7567), 519-521. doi: 10.1136/bmj.38925.471146.4F