Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation

Condition(s) targeted: Pain

Intervention: ketorolac (Drug); morphine (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)

Official(s) and/or principal investigator(s):
James C. Eisenach, M.D., Principal Investigator, Affiliation: Wake Forest University
Richard Rauck, M.D., Principal Investigator, Affiliation: The Center for Clinical Research

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

Official title: Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Primary outcome:

VAS pain.

Primary analysis will be the comparison between ketorolac and placebo groups.

Secondary outcome: Change in oral opioid dose.

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Starting date: December 2006
Last updated: January 5, 2007