2022-502502-32-00招募中4 期
Safety of ibuprofen after major orthopaedic surgeries - the PERISAFE randomized clinical multicentre trial
Slagelse Hospital, Slagelse Hospital9 个研究点 分布在 1 个国家目标入组 2,904 人开始时间: 2023年3月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,904
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
We aim to assess the beneficial and harmful effects of an eight day postoperative treatment with ibuprofen, a non-selective NSAID and one of the most used non-opioid analgesics, after elective hip and knee arthroplasties.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Daniel Hägi-Pedersen
Scientific
Slagelse Hospital
研究点 (9)
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