Effect of Spinal Ketorolac After Acute Opioid Exposure

NCT00693160 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00002457GM48085
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
2. 2.What pain relieving effects does spinal ketorolac have when given with IV remifentanil?

Conditions

Healthy

Keywords

healthy volunteers; analgesia; pain; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration

  2.5 hours

Study Arms (2)

Intrathecal Ketorolac

EXPERIMENTAL

In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.

Drug: ketorolac; Drug: remifentanil; Drug: Capsaicin

Placebo intrathecal injection

PLACEBO COMPARATOR

In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment.

Drug: placebo; Drug: remifentanil; Drug: Capsaicin

Interventions

ketorolac DRUG

single intrathecal injection of ketorolac 2 mg

Also known as: toradol, acular pf

Intrathecal Ketorolac

placebo DRUG

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

Placebo intrathecal injection

remifentanil DRUG

All subjects will receive a remifentanil infusion

Also known as: ultiva

Intrathecal Ketorolac; Placebo intrathecal injection

Capsaicin DRUG

Topical capsaicin pain model utilized for each subject

Intrathecal Ketorolac; Placebo intrathecal injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• American Society of Anesthesiologist (ASA) I or II classification
• between the ages of 18-55
• weigh less than 250 pounds
• without chronic pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Ketorolac; Ketorolac Tromethamine; Remifentanil; Capsaicin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Polyunsaturated Alkamides; Amides; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: James C. Eisenach, M.D.
• Organization: Wake Forest School of Medicine

jimeisenach@gmail.com

336-716-4498

Study Officials

• James C. Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: June 6, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 7, 2018
• Results First Posted: April 14, 2014

Record last verified: 2018-08

Locations

US (1)