The Adverse Effects Associated With Ibuprofen Use After Major Orthopaedic Surgeries-A Detailed Statistical Analysis Plan for the PERISAFE Randomized Clinical Trial.

ABSTRACT: The PERISAFE trial aims to assess the adverse effects associated with an 8-day postoperative treatment with ibuprofen after hip and knee arthroplasties. This paper outlines the detailed statistical analysis plan for the primary data. The PERISAFE trial is a randomized, placebo-controlled, blinded multicentre trial allocating 2904 hip- or knee-arthroplasty patients 1:1 to ibuprofen 400 mg ×3/day or identical placebo ×3/day for 8 days postoperatively. The primary outcome is a composite of 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 outcomes are hospital-free days within 90 days postoperatively, a composite of ibuprofen and o

SUBMITTER: Laursen CCW 

PROVIDER: S-EPMC12117996 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature