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| Sponsor: | Wake Forest University |
|---|---|
| Information provided by: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00349401 |
Purpose
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: ketorolac Drug: morphine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2006 |
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).
To treat persons with chronic pain, doctors sometimes implant a permanent tube in the spinal space in the back to give pain medicines. This tube, also called a spinal pump, is used to administer pain medicine directly to the spinal space. The most commonly used medicine given through the spinal pump is morphine which works well for most people, but sometimes loses tolerance, and larger and larger doses are needed, causing many side effects.
The purpose of this study is to find out if another medicine, ketorolac, when given with morphine in the spinal space, can stop or reverse the need for larger and larger doses of morphine. In animals, ketorolac has been shown to slow the need for an increase in morphine dosage and to reduce the morphine dose, while giving good pain control.
This study will enroll 30 individuals with chronic pain below the chest, caused by nerve injury, who are receiving morphine through a spinal pump. After learning to estimate pain accurately using thermal heat testing, participants will be randomly assigned to one of two study groups. Group one will receive the active study medication, ketorolac, while group two receives an inactive control (placebo). All participants will receive morphine (administered through the spinal pump). Afterwards, participants will rate their levels of pain, and provide samples of their spinal fluid (taken from the spinal tube/pump) for study. The above procedure will be repeated over a 4-week period.
Duration of the study for participants is 4 weeks, and includes ten visits to the research center, each lasting less than one hour.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00349401 History of Changes |
| Other Study ID Numbers: | P01NS041386_TRIAL3 |
| Study First Received: | July 5, 2006 |
| Last Updated: | May 12, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
pain chronic pain morphine ketorolac |
|
Morphine Ketorolac Ketorolac Tromethamine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Central Nervous System Depressants Narcotics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |