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Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation

This study has been withdrawn prior to enrollment.
(Study was not initiated. No subjects were screened or enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00349401
First Posted: July 7, 2006
Last Update Posted: June 3, 2015
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.
Information provided by:
Wake Forest University Health Sciences
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • VAS pain.
  • Primary analysis will be the comparison between ketorolac and placebo groups.

Secondary Outcome Measures:
  • Change in oral opioid dose.

Enrollment: 0
Study Start Date: December 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: James C. Eisenach, M.D. Wake Forest University Health Sciences
Principal Investigator: Richard Rauck, M.D. The Center for Clinical Research
  More Information

ClinicalTrials.gov Identifier: NCT00349401     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL3
P01NS041386 ( U.S. NIH Grant/Contract )
First Submitted: July 5, 2006
First Posted: July 7, 2006
Last Update Posted: June 3, 2015
Last Verified: May 2009

Keywords provided by Wake Forest University Health Sciences:
pain
chronic pain
morphine
ketorolac

Additional relevant MeSH terms:
Morphine
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action