Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pain chronic pain morphine ketorolac

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ketorolac

Intervention Type DRUG

morphine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James C. Eisenach, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Richard Rauck, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Center for Clinical Research

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P01NS041386

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01NS041386_TRIAL3

Identifier Type: -

Identifier Source: org_study_id