Safety of ibuprofen after major orthopaedic surgeries - the PERISAFE randomized clinical multicentre trial

Conditions

Acute postoperative pain, Hip and knee arthroplasties

Brief summary

A composite outcome of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively.

Detailed description

Hospital free days within 90 days postoperatively., A composite outcome of ibuprofen related adverse events based on eight-day postoperative diary: pain or discomfort from the epigastrium, reflux, diarrhoea., A composite outcome of opioid related adverse events based on eight-day postoperative diary: nausea, vomiting, constipation, sedation, headache, mood changes, mouth dryness., Health related quality of life questionnaire via EQ-5D-5L after 90 days and one year postoperatively.

Laursen CCW, Lund KN, Lunn TH, Hägi-Pedersen D, Therkelsen ASN, Steensbæk MT, Faugstad BI, Anjum S, Yilmaz M, Pedersen NA, Kappel A, Graungaard BK, Hollænder PB, Runge C, Lange KHW, Varnum C, Brorson S, Lindberg-Larsen M, Overgaard S, Olsen MH, Jakobsen JC, Mathiesen O.

2026-04-01

10.1111/aas.70218

Interventions

DRUGIdentical capsule

DRUGIbuprofen 400 mg

DRUGtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
A composite outcome of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively.	—

Secondary

Measure	Time frame
Hospital free days within 90 days postoperatively., A composite outcome of ibuprofen related adverse events based on eight-day postoperative diary: pain or discomfort from the epigastrium, reflux, diarrhoea., A composite outcome of opioid related adverse events based on eight-day postoperative diary: nausea, vomiting, constipation, sedation, headache, mood changes, mouth dryness., Health related quality of life questionnaire via EQ-5D-5L after 90 days and one year postoperatively.	—

Measure

Time frame

Hospital free days within 90 days postoperatively., A composite outcome of ibuprofen related adverse events based on eight-day postoperative diary: pain or discomfort from the epigastrium, reflux, diarrhoea., A composite outcome of opioid related adverse events based on eight-day postoperative diary: nausea, vomiting, constipation, sedation, headache, mood changes, mouth dryness., Health related quality of life questionnaire via EQ-5D-5L after 90 days and one year postoperatively.

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Countries

Denmark

Outcome results

None listed