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临床试验/NCT03324815
NCT03324815Unknown不适用

Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月2日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Morphine 5mg/6h plus metadone: 2,5mg/12h

干预措施: Morphine (Drug)

Morphine- Methadone

Active Comparator

Morphine 5mg/6h plus metadone: 2,5mg/12h

干预措施: Methadone (Drug)

Morphine

Active Comparator

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

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Feliciano Contardo Nepomuceno Duarte

Principal Investigator

Federal University of São Paulo

研究点 (1)

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