Safety of ibuprofen after major orthopaedic surgeries
Phase 1
Recruiting
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Acute postoperative pain, Hip and knee arthroplasties
- Registration Number
- CTIS2022-502502-32-00
- Lead Sponsor
- Slagelse Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2904
Inclusion Criteria
Scheduled for planned primary hip or knee arthroplasty, including hemiarthroplasty., Age = 18 years., Planned perioperative pain treatment with NSAID, decided by the clinical doctor., Negative urine Human Chorionic Gonadotropin (hCG) pregnancy test and use of anti-conception for women in fertile age., Written informed consent.
Exclusion Criteria
Patients unable to understand or speak Danish., Allergy to, or contraindications against ibuprofen, including heart insufficient (NYHA IV), severe thrombocytopenia (< 50 x 10^9/l), asthma triggered by NSAID, or known renal impairment (eGFR < 60 ml/min), previous ulcer due to NSAID treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method