Effect of Spinal Ketorolac After Acute Opioid Exposure

Healthy Clinical Trial

Official title:

Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00693160
• Other study ID #: IRB00002457
• Secondary ID: GM48085
• Status: Terminated
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ketorolac
single intrathecal injection of ketorolac 2 mg
• placebo
subject will receive a placebo (preservative free normal saline) spinal injection
• remifentanil
All subjects will receive a remifentanil infusion
• Capsaicin
Topical capsaicin pain model utilized for each subject

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperalgesia	Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament	24 hours
Secondary	Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration	Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac	2.5 hours