Celecoxib for Treatment of Postoperative Pain After Osteosynthesis of Distal Radius Fracture

Celecoxib in radius fracture

Patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (PO) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. After surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (IV) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (NRS) of 0-10, piritramid 15 mg intramuscularly (IM) will be administered. Pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.

2022-02-10

2023-11-30

2023-12-31

Completed

Early phase I

42

Inclusion Criteria: * Patients scheduled for osteosynthesis of distal radius fracture Exclusion Criteria: * Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib * History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. * Patients who have demonstrated allergic-type reactions to sulfonamides. * Inability to understand the questionnaire

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Celecoxib 100 mg orally on the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Placebo pill provided by a hospital pharmacy will be administered orally on the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2024-02-07