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

doi:10.1136/bmj.38925.471146.4F

BMJ 2006;333:519 (9 September), doi:10.1136/bmj.38925.471146.4F (published 2 August 2006)

Research

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, senior research fellow¹, Craig Anderson, director, neurological and mental health division¹, Jan Douglas, project manager¹, Stephen MacMahon, principal director¹, Bruce Neal, director, cardiac and renal division¹, Robyn Norton, principal director¹, Mark Woodward, director, epidemiology and biostatistics division¹, Ian D Cameron, director and professor of rehabilitation medicine², Ross Crawford, professor of orthopaedic research³, Sing Kai Lo, associate professor of biostatistics⁴, Garnet Tregonning, orthopaedic surgeon⁵, Margaret Windolf, research nurse⁶, HIPAID Collaborative Group

¹ The George Institute for International Health, University of Sydney, Australia, ² Faulty of Medicine, University of Sydney, Australia, ³ Queensland University of Technology, Australia, ⁴ Deakin University, Melbourne, Australia, ⁵ Middlemore Hospital, Auckland, New Zealand, ⁶ Royal Prince Alfred Hospital, NSW, Australia

Correspondence to: M Fransen mfransen{at}george.org.au

Abstract

Objectives To determine the benefits and risks of a non-steroidalanti-inflammatory drug (NSAID) as prophylaxis for ectopic boneformation 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 NewZealand.

Participants 902 patients undergoing elective primary or revisiontotal 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 andphysical function 6 to 12 months after surgery (Western Ontarioand McMaster University Arthritis index).

Results There were no significant differences between the groupsfor improvements in hip pain (mean difference -0.1, 95% confidenceinterval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4to 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 complicationsin the ibuprofen group during the admission period (2.09, 1.00to 4.39).

Conclusions These data do not support the use of routine prophylaxiswith NSAIDs in patients undergoing total hip replacement surgery.

Trial registration NCT00145730 [ClinicalTrials.gov] .

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Closs, S J. (2007). Postoperative ibuprofen increased bleeding complications in hospital and did not improve pain or physical function at 6-12 months after total hip replacement. Evid. Based Nurs. 10: 57-57 [Full text]
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Rapid Responses:

Read all Rapid Responses

Bleeding and NSAIDs: James S Dawson
bmj.com, 10 Sep 2006 [Full text]
Optimal management requires correct dose by the correct route and at the correct time: Hamzeh Hussein, et al.
bmj.com, 14 Sep 2006 [Full text]
Re: Bleeding and NSAIDs: Marlene Fransen
bmj.com, 15 Sep 2006 [Full text]
Re: Optimal management requires correct dose by the correct route and at the correct time: Marlene Fransen
bmj.com, 15 Sep 2006 [Full text]
NSAIDs are very useful after hip replacement surgery: David J Wilkinson, et al.
bmj.com, 20 Sep 2006 [Full text]