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. 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Recruitment Status : Withdrawn (Study was not initiated.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
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.

Condition or disease Intervention/treatment Phase
Pain Drug: ketorolac Drug: morphine Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
Study Start Date : December 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Change in oral opioid dose.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00349401

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

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00349401     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL3
P01NS041386 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: May 2009

Keywords provided by Wake Forest University Health Sciences:
chronic pain

Additional relevant MeSH terms:
Ketorolac Tromethamine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
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