Effect of Spinal Ketorolac After Acute Opioid Exposure
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: ketorolac (Drug); placebo (Drug); remifentanil (Drug); Capsaicin (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s): James C. Eisenach, M.D., Principal Investigator, Affiliation: Wake Forest School of Medicine
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?
Clinical Details
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Hyperalgesia
Secondary outcome: Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
Additional Information
Starting date: December 2007
Last updated: March 7, 2014
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