- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349401
Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
Study Overview
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).
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Implanted spinal pump for at last 9 months
- Must be receiving and the dose must have been doubled in the past 6 months
- Currently taking 60-200 mg morphine equivalent as oral rescue per day
- Men and women, ages 18-70
- Weigh no more that 250 pounds
- Neuropathic pain
Exclusion Criteria:
- Pregnancy
- Unstable medical problems (heart lung, liver, kidney, or nervous system)
- Allergy to morphine, ketorolac, or drugs which may be used to treat side effects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
VAS pain.
|
Primary analysis will be the comparison between ketorolac and placebo groups.
|
Secondary Outcome Measures
Outcome Measure |
---|
Change in oral opioid dose.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Ketorolac
- Morphine
Other Study ID Numbers
- P01NS041386_TRIAL3
- P01NS041386 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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