|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Wake Forest University National Institute of General Medical Sciences (NIGMS) |
|---|---|
| Information provided by: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00693160 |
Purpose
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in your back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. ¬The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller):
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: ketorolac Drug: placebo Drug: remifentanil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
subject will receive a single intrathecal injection of ketorolac 2 mg
|
Drug: ketorolac
single intrathecal injection of ketorolac 2 mg
Drug: remifentanil
narcotic comparator will be given to all subjects
Drug: remifentanil
All subjects will receive a remifentanil infusion
|
|
2: Placebo Comparator
subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
|
Drug: placebo
subject will receive a placebo (preservative free normal saline) spinal injection
Drug: remifentanil
All subjects will receive a remifentanil infusion
|
Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased CSF PGE2 concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.
Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure CSF PGE2 concentration after stopping remifentanil.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Regina Currry, RN, CCRC | 336-716-4294 | recurry@wfubmc.edu |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: James C. Eisenach, M.D. | |
| Sub-Investigator: Chuanyao Tong, M.D. | |
| Principal Investigator: | James C. Eisenach, M.D. | Wake Forest University |
More Information
| Responsible Party: | Wake Forest University Health Sciences ( James C. Eisenach, M.D. ) |
| Study ID Numbers: | IRB00002457, GM48085 |
| Study First Received: | February 15, 2008 |
| Last Updated: | January 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00693160 |
| Health Authority: | United States: Food and Drug Administration |
|
healthy volunteers analgesia pain Healthy subjects |
|
Hypersensitivity Remifentanil Ketorolac |
Pain Healthy Ketorolac Tromethamine |
|
Anesthetics, Intravenous Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Anesthetics Central Nervous System Depressants Enzyme Inhibitors Pharmacologic Actions Anesthetics, General |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |
