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

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38925.471146.4F (Published 07 September 2006) Cite this as: BMJ 2006;333:519

Re: Optimal management requires correct dose by the correct route and at the correct time

The comments made by Dr Hussein and Dr Toner-Sho regarding the dose-
response relationship for adverse events associated with NSAIDs use are
well-supported by the literature.

As regards the comments concerning the safety of participants who received
regional anaesthesia is our study, this issue was discussed by the members
of the HIPAID Management Committee at the time of developing the study
design. Spinal or epidural anaesthesia is traditionally considered contra-
indicated in patients with significant disorders of blood coagulation, due
to an increased risk of the rare event of spinal haematoma causing neural
damage. However, there is no agreement about its risk among patients
whose coagulation may be mildly altered by low to moderate doses of
NSAIDs.1 It was decided, however, that patients receiving regional
anaesthesia would be ineligible for study participation unless any spinal
catheter had been removed at least 2 hours prior to randomisation.2 It
was also concluded that any variations in the use of NSAIDs or number of
outpatient appointments and physiotherapy visits between patients during
the follow-up period would be balanced by the randomisation procedure in
this large study.

1. Royal College of Anaesthetists. Guidelines for the use of non-
steroidal anti-inflammatory drugs in the perioperative period. 1998.

2. Horlocker TT, et al. Low molecular weight heparin: biochemistry,
pharmacology, perioperative prophylaxis regimens, and guidelines for
regional anesthetic management. Anesthesia Analgesia. 1997;85:874-885.

Competing interests:
None declared

Competing interests: No competing interests

15 September 2006
Marlene Fransen
Senior Research Fellow
The George Institute