Clonidine Versus Adenosine to Treat Neuropathic Pain
- Registration Number
- NCT00349921
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
- Detailed Description
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.
Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description adenosine first, then clonidine adenosine adenosine given in first injection clonidine given in second injection clonidine given first, then placebo placebo placebo adenosine given first, then placebo placebo placebo clonidine first, then adenosine clonidine clonidine given in first injection adenosine given in second injection
- Primary Outcome Measures
Name Time Method Number Meeting Success Criterion baseline and 2 hours Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The Center for Clinical Research, 145 Kimel Park Drive
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine, Medical Center Boulevard
🇺🇸Winston-Salem, North Carolina, United States