Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00349401|
Recruitment Status : Withdrawn (Study was not initiated. No subjects were screened or enrolled.)
First Posted : July 7, 2006
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: ketorolac Drug: morphine||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation|
|Study Start Date :||December 2006|
- VAS pain.
- Primary analysis will be the comparison between ketorolac and placebo groups.
- Change in oral opioid dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349401
|Principal Investigator:||James C. Eisenach, M.D.||Wake Forest University Health Sciences|
|Principal Investigator:||Richard Rauck, M.D.||The Center for Clinical Research|