Clonidine Versus Adenosine to Treat Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number Meeting Success Criterion
研究概览
简要总结
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
详细描述
This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).
Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.
Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain.
After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity
排除标准
- •Pregnancy
- •Allergy to clonidine
- •Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
- •Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)
研究组 & 干预措施
clonidine first, then adenosine
clonidine given in first injection adenosine given in second injection
干预措施: clonidine (Drug)
adenosine first, then clonidine
adenosine given in first injection clonidine given in second injection
干预措施: adenosine (Drug)
clonidine given first, then placebo
placebo
干预措施: placebo (Drug)
adenosine given first, then placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number Meeting Success Criterion
时间窗: baseline and 2 hours
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
次要结局
未报告次要终点
