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临床试验/CTRI/2019/02/017850
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

发起方
Akums Drugs Pharmaceutical Ltd India

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