Effect of Spinal Ketorolac After Acute Opioid Exposure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-01-31

Brief Summary

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

This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous \[IV\] narcotic painkiller):

1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketorolac on Posterior Thoracolumbar Spinal Fusions

NCT03278691

Thoracolumbar Spinal Fusions

RECRUITING PHASE4

The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

NCT02085577

Postoperative Pain Chronic Pain Analgesics

COMPLETED PHASE4

Relieving Acute Pain (RAP) Study: A Pilot Study

NCT03426137

Trauma Opioid Use Spine Fusion

TERMINATED PHASE2

Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

NCT03678675

Post-operative Pain Post-partum Pain Cesarean Section Complications

COMPLETED PHASE3

Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients

NCT03088306

Lumbar Spinal Stenosis Lumbar Spinal Instability Lumbar Spine Degeneration

COMPLETED EARLY_PHASE1

Detailed Description

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

Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.

Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure Cerebrospinal fluid (CSF) prostaglandin E2 (PGE2) concentration after stopping remifentanil.

Conditions

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

Healthy

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathecal Ketorolac

In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.

Group Type EXPERIMENTAL

ketorolac

Intervention Type DRUG

single intrathecal injection of ketorolac 2 mg

remifentanil

Intervention Type DRUG

All subjects will receive a remifentanil infusion

Capsaicin

Intervention Type DRUG

Topical capsaicin pain model utilized for each subject

Placebo intrathecal injection

In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subject will receive a placebo (preservative free normal saline) spinal injection

remifentanil

Intervention Type DRUG

All subjects will receive a remifentanil infusion

Capsaicin

Intervention Type DRUG

Topical capsaicin pain model utilized for each subject

Interventions

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

ketorolac

single intrathecal injection of ketorolac 2 mg

Intervention Type DRUG

placebo

subject will receive a placebo (preservative free normal saline) spinal injection

Intervention Type DRUG

remifentanil

All subjects will receive a remifentanil infusion

Intervention Type DRUG

Capsaicin

Topical capsaicin pain model utilized for each subject

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

toradol acular pf ultiva

Eligibility Criteria

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

Inclusion Criteria

* healthy
* American Society of Anesthesiologist (ASA) I or II classification
* between the ages of 18-55
* weigh less than 250 pounds
* without chronic pain

Exclusion Criteria

* taking analgesics in the last 2 weeks
* positive urine drug screen
* pregnancy
* currently taking any prescription antidepressants or other medications that are mood altering
* liver or kidney disease
* stomach ulcers
* allergies to ketorolac, lidocaine, or capsaicin cream
* lung disease (COPD)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes