EUCTR2015-004482-88-ES进行中（未招募）1 期
Randomized clinical trial to compare the safety and effectiveness of metamizol, ibuprofen and tramadol added to a fixed dose of paracetamol in the treatment of post- surgical pain in patients ? 80 year after an intervention to repare a fracture of the proximal third of the femur, admitted to a convalescence unit
Fundació Parc Taulí0 个研究点开始时间: 2016年3月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients ? 80 years
- •-Patients undergoing surgery for fracture of the proximal femur
- •-Patients candidates for oral treatment with any of the study drugs
- •-Patients who give their informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Patients who, at the discretion of the investigator are not able to consent or participate in study assessments (Neurologic impairment such as senile dementia or other that may impair the pain assessment and response to analgesic treatment)
- •Patients with contraindications to the drugs studied according to the summary of product characteristics (SPC).
- •Patients with creatinine clearance <50 ml / min
- •Patients with blood dyscrasias (anemia, thrombocytopenia, agranulocytosis, aplastic anemia)
- •Patients with severe hypotension
- •Patients with hepatic cirrosis or previous upper gastrointestinal bleeding
- •Patients on chronic treatment with drugs that may not be administered together with the study medication according to the SPC
- •Patients receiving treatment with NSAIDs, metamizol or opioids in a continuous schedule with good compliance reported within the previous month before inclusion into the study. As needed consumption within the previous month are allowed.
- •Patients with chronic pain that could interfere with the study assessments
- •The physician responsible for patient's care considers that the participation of the patient in the study could be a prejudice
研究者
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