Clinical trial NCT00693160: Effect of Spinal Ketorolac After Acute Opioid Exposure
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Healthy
Keywords: healthy volunteers
analgesia
pain
Healthy subjects
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2008-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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?

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 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)

Primary outcomes:
measure: Hyperalgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
timeFrame: 2.5 hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C. Eisenach, M.D.
role: PRINCIPAL_INVESTIGATOR
References: