CTRI/2019/02/017850尚未招募3 期
A multi-centric, comparative, randomized, double blind, parallel group, phase III clinical trial study to evaluate efficacy, safety & tolerability of the continuous intravenous infusion of Tramadol Infusion 0.1 % w/v versus Tramadol 50 mg/ ml injection for the treatment of patients with postoperative pain
Akums Drugs Pharmaceutical Ltd India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy).
- •2 Hospital stay at least for 24 hours is needed.
- •3 Cooperative and understanding skills.
- •4 Agreement to informed consent form.
排除标准
- •1 Hypersensitivity to any of the drugs components or other drug from same class.
- •2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study
- •3 Patient with history of drug of abuse.
- •4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache.
- •5 Pregnant and lactating woman
研究者
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