CTRI/2010/091/000096已完成3 期
A Randomized, Parallel Group, Comparative Study Evaluating the Efficacy and Tolerability of Injection Diclofenac Sodium 75mg/1mL given as an IV Injection versus Diclofenac Sodium 75mg/3mL given as an Infusion in the management of Post Operative Pain.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
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
- •1Patients in the age group of 18 to 60 years
- •2Patients of both sexes
- •3Patients undergoing elective day surgery with moderate to severe pain
- •4Patients with moderate to severe pain at baseline (VAS score greater than or equal to 4)
排除标准
- •1. Patients below 18 years and above 60 years of age
- •2. Patients with compromised renal function
- •3. Pregnant and lactating women
- •4. Patients with history of bronchial asthma, peptic ulceration, bronchitis
- •5. Patients with coagulation disorders (esp. bleeding disorders)
- •6. Mentally retarded patients
- •7. Unwilling patients
- •8. Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations
- •9. Patients with mild baseline pain (VAS < 4)
研究者
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