Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.
详细描述
Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Approved by the Ethics Committee
- •signed the informed consent
- •cancer pain
- •starting the WHO thirth analgesic ladder,
排除标准
- •cognitive impairment
- •psychiatric disease
- •illicit drug user
- •hypersensitivity to the study drugs
研究组 & 干预措施
Morphine- Methadone
Morphine 5mg/6h plus metadone: 2,5mg/12h
干预措施: Morphine (Drug)
Morphine- Methadone
Morphine 5mg/6h plus metadone: 2,5mg/12h
干预措施: Methadone (Drug)
Morphine
Morphine: 5mg/6h
干预措施: Morphine (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 3 months
Total dose of morphine used by the patient
次要结局
- Pain intensity(3 months)
研究者
Feliciano Contardo Nepomuceno Duarte
Principal Investigator
Federal University of São Paulo
