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临床试验/NCT00349921
NCT00349921已完成2 期

Clonidine Versus Adenosine to Treat Neuropathic Pain

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

clonidine given in first injection adenosine given in second injection

干预措施: clonidine (Drug)

adenosine first, then clonidine

Active Comparator

adenosine given in first injection clonidine given in second injection

干预措施: adenosine (Drug)

clonidine given first, then placebo

Placebo Comparator

placebo

干预措施: placebo (Drug)

adenosine given first, then placebo

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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