Effect of Spinal Ketorolac After Acute Opioid Exposure

Summary

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?

Conditions

• Healthy

Interventions

DRUG

ketorolac

single intrathecal injection of ketorolac 2 mg

DRUG

placebo

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

DRUG

remifentanil

All subjects will receive a remifentanil infusion

DRUG

Capsaicin

Topical capsaicin pain model utilized for each subject

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• Wake Forest University

  lead OTHER

Principal Investigators

• James C. Eisenach, M.D. · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2010-10-31

Completion

2011-01-31

FDA Drug

Yes

Countries

• United States

Study Locations