Comparison of Oral Methadone versus Morphine As a First- Line Strong Opioid for Cancer Pain: A Randomized Double -Blind study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare effectiveness of oral Methadone versus oral Morphine in cancer patient using an 11- point NRS and ESC -CP score in reducing pain in cancer patient
研究概览
简要总结
Malignant pain often have different pain mechanism due to different pain receptors involvement, to adress that a combination of different pain medications are used . Conventional opioids are the backbone of the treatment of cancer pain. Conventional opioids like Morphine acts mainly by binding the Mu opioid receptors .These Mu receptors are found in multiple locations pre-synaptically and post-synaptically. But pain relief in cancer patient via other receptors remains unaddressed. Hence to see the feasibility of methadone with that unaddressed receptors we are conducting this study.
Our primary objective in this study is To compare Effectivness of Oral Methadone versus Morphine as a fFrst line Strong Opioid in reducing pain in cancer patient.
Our secondary objecties are to compare -1.Cost effectivness of Methadone versus Morphine.
2.Side effects of Methadone versus Morphine.
3.Opioid escalation index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All ages between 18 and 70 years Cancer patients Numerical Rating Score (NRS) for pain more than or equal to 5 Edmonton Classification System for Cancer Pain (ECS CP) Showing Ne (NEUROPATHIC and NOCIPECTIVE) Willing for informed consent.
排除标准
- •Patient’s refusal to participate in the study Patient not mentally competent to report From far places who cannot be followed up Patient with cardiac issues, abnormal baseline ECG and documented arrhythmias.
结局指标
主要结局
To compare effectiveness of oral Methadone versus oral Morphine in cancer patient using an 11- point NRS and ESC -CP score in reducing pain in cancer patient
时间窗: 0,7th,14th,21th,28th,35th,42th days
次要结局
- To compare-(1. Cost effectiveness of Methadone vs Morphine.)
研究者
Dr Samreen Shaikh
Bharati Vidyapeeth(Deemed to be University) Medical College, Pune