The adverse effects with ibuprofen after major orthopedic surgeries: A protocol for the PERISAFE randomized clinical trial
Study context
- Population
- Patients undergoing elective hip or knee arthroplastyplanned sample size
- Participants
- 2,904 patients
- Planned comparison
- Ibuprofen vs Placebo
- Primary endpoint
- Composite of:
- Death
- Acute MI
- Stroke
- PE
- DVT
- Renal failure
- Major bleeding
- Re-operation
- Gastrointestinal ulcer
- Readmission
- Follow-up
- Within 90 days postoperatively
Methodological detailsplacebo-controlled, blinded, multicentre, Allocation 1:1; 90-day and one-year follow-up, Primary analysis in modified ITT population, Secondary outcomes: hospital-free days within 90 days, composite of ibuprofen- and opioid-related adverse reactions (8-day diary), health-related quality of life after 90 days, Sample size of 2904 to demonstrate RR reduction of 33% (type I error 5%, type II error 20%, serious adverse events in ibuprofen group 8%)
- Placebo-controlled
- Blinded
- Multicentre
- Allocation 1:1; 90-day and one-year follow-up
- Primary analysis in modified ITT population
- Secondary outcomes: hospital-free days within 90 days, composite of ibuprofen- and opioid-related adverse reactions (8-day diary), health-related quality of life after 90 days
- Sample size of 2904 to demonstrate RR reduction of 33% (type I error 5%, type II error 20%, serious adverse events in ibuprofen group 8%)
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The adverse effects with ibuprofen after major orthopedic surgeries: A protocol for the PERISAFE randomized clinical trial. Acta Anaesthesiol Scand. Published 30 January 2025. doi:10.
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