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临床试验/NCT02233452
NCT02233452已完成4 期

Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial

Universidade Federal de Santa Maria1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
37
试验地点
1
主要终点
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores

研究概览

简要总结

Methadone and ketamine are effective for neuropathic pain management. However, the benefits of the association of both drugs are uncertain. Here, the investigators conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

详细描述

Either oral methadone or ketamine have been used in neuropathic pain management, however, the benefits of the association of both drugs are uncertain. Here, we conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

Methods: Fourthly two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive during three months oral methadone (n= 13), ketamine (n=13) or methadone combined with ketamine (n=13). The primary outcome was pain score on visual analogical scale (VAS) assessed on baseline, 8, 15, 30, 60 and 90 days throughout the treatment, and the secondary outcomes were symptoms of neuropathic pain such as allodynia, burning or shooting pain as well the side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients complaining of pain for more than 6 months with neuropathic pain poorly responsive to drugs used to treat neuropathic pain (i.e. opioid, non-opioid, anticonvulsants, antidepressants), who were 22 to 77 years old

排除标准

  • patients with a history of severe psychiatric disorder,
  • misuse of illegal drugs or
  • hepatic disease

研究组 & 干预措施

Methadone

Active Comparator

Group treated with methadone solution.

干预措施: Methadone (Drug)

Ketamine

Active Comparator

Group treated with ketamine solution

干预措施: Ketamine (Drug)

Methadone plus ketamine

Active Comparator

Group treated with methadone plus ketamine solution

干预措施: Methadone plus Ketamine (Drug)

结局指标

主要结局

The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores

时间窗: 90 days

次要结局

  • The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects.(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliano Ferreira

PhD

Universidade Federal de Santa Maria

研究点 (1)

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