Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial
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
- 否
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
Group treated with methadone solution.
干预措施: Methadone (Drug)
Ketamine
Group treated with ketamine solution
干预措施: Ketamine (Drug)
Methadone plus ketamine
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
Juliano Ferreira
PhD
Universidade Federal de Santa Maria