Effect of Spinal Ketorolac After Acute Opioid Exposure



Status:Terminated
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:9/9/2018
Start Date:December 2007
End Date:January 2011

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Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure

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?

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.

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)
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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