Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. However, methadone usage for pain control in Thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic noncancer and cancer pain.
详细描述
Chronic pain is defined as pain that persists beyond normal tissue healing time, which is assumed for 3 months by the IASP. The symptoms include either continuous or intermittent pain, that could be caused by tumor or other multiple etiologies. The consequence of uncontrolled chronic pain presents not only physiologic symptoms but also psychiatric disorders leading to severely impact daily living.
In Thailand, the use of methadone for pain management has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, the aim of this study is to evaluate the efficacy and safety of a protocol of methadone dosing in outpatients with severe chronic pain.
Thirty four chronic pain patients will be included to initiate methadone use following the protocol. Pain scores, pain interferences scores, neuropathic pain score, severity of adverse effects, and QTc intervals will be assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
The approved protocol of methadone therapy obtained from this study could be clinically utilized by physicians for severe chronic pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics
排除标准
- •QTc interval that was more than 500 msec
- •History of opioid addiction
- •Having structural heart diseases
- •During pregnancy or lactation period
- •Patients who have hypersensitivity to methadone
研究组 & 干预措施
methadone
single group
干预措施: Methadone (Drug)
结局指标
主要结局
Pain score
时间窗: 3 months
pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
次要结局
- pain interferences scores(3 months)
- severity of adverse effects(3 months)
- QTc intervals(3 months)
- Neuropathic pain score(3 months)