CTRI/2023/10/058966招募中4 期
Comparison of Ketamine Vs Lignocaine intravenous infusion in refractory cancer pain
Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年10月30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
- 66
- 试验地点
- 1
- 主要终点
- Comparison of Ketamine Vs Lignocaine intravenous infusion in refractory cancer pain in reducing severity of pain atleast by 50%
研究概览
简要总结
This study is a randomized, double blind, parallel group, comparing the lignocaine 2mg/kg/hr IV infusion and Ketamine 0.3mg/kg/hr IV infusion over 6hrs -2 infusions with 12hrs apart , efficacy in reducing the refractory cancer pain in 66 patients that will be conducted in one center in India. The primary outcome will be comparison of both the drugs in reducing severity of refractory cancer pain at least by 50% and secondary outcome will be comparison of side effect profile and tolerability of both drugs and time interval of next relapse of acute pain crisis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Refractory cancer pain with NRS >6-7/10 despite optimal opioid drugs (OME >300 mg / day) Patients with refractory neuropathic/mixed pain Patients with life span >8weeks.
排除标准
- •H/O psychosis Any liver, kidney and heart abnormalities Patients with altered cognitive function H/O drugs hypersensitivity Patients not giving consent.
结局指标
主要结局
Comparison of Ketamine Vs Lignocaine intravenous infusion in refractory cancer pain in reducing severity of pain atleast by 50%
时间窗: 1 year
次要结局
- 1.Comparison of side effect profile & tolerability of both drugs(2.Comparison of time interval in both drugs till next relapse of acute pain crisis)
研究者
研究点 (1)
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