Effect of Spinal Ketorolac After Acute Opioid Exposure
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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):
- How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
- What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: ketorolac Drug: placebo Drug: remifentanil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure |
- primary outcome measure is the area of hyperalgesia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- secondary outcome measure is the CSF PGE2 concentration after stopping remifentanil [ Time Frame: 2.5 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
subject will receive a single intrathecal injection of ketorolac 2 mg
|
Drug: ketorolac
single intrathecal injection of ketorolac 2 mg
Other Names:
Drug: remifentanil
All subjects will receive a remifentanil infusion
Other Name: ultiva
|
|
Placebo Comparator: 2
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
Other Name: placebo
Drug: remifentanil
All subjects will receive a remifentanil infusion
Other Name: ultiva
|
Detailed Description:
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:
- healthy
- ASA I or II classification
- between the ages of 18-55
- weigh less than 250 pounds
- without chronic pain
Exclusion Criteria:
- taking analgesics in the last 2 weeks
- positive urine drug screen
- pregnancy
- currently taking any prescription antidepressants or other medications that are mood altering
- liver or kidney disease
- stomach ulcers
- allergies to ketorolac, lidocaine, or capsaicin cream
- lung disease (COPD)
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | James C. Eisenach, M.D. | Wake Forest University |
More Information
No publications provided
| Responsible Party: | James C. Eisenach, M.D., Professor, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00693160 History of Changes |
| Other Study ID Numbers: | IRB00002457, GM48085 |
| Study First Received: | February 15, 2008 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wake Forest University:
|
healthy volunteers analgesia pain Healthy subjects |
Additional relevant MeSH terms:
|
Ketorolac Ketorolac Tromethamine Remifentanil Analgesics, Opioid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013