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Effect of Spinal Ketorolac After Acute Opioid Exposure

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ClinicalTrials.gov Identifier: NCT00693160
Recruitment Status : Terminated (the manufacturing of preservative free ketorolac (Acular-PF) was discontinued)
First Posted : June 6, 2008
Results First Posted : April 14, 2014
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE February 15, 2008
First Posted Date  ICMJE June 6, 2008
Results First Submitted Date  ICMJE May 15, 2013
Results First Posted Date  ICMJE April 14, 2014
Last Update Posted Date September 7, 2018
Study Start Date  ICMJE December 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Hyperalgesia [ Time Frame: 24 hours ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
primary outcome measure is the area of hyperalgesia [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT00693160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration [ Time Frame: 2.5 hours ]
Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
secondary outcome measure is the CSF PGE2 concentration after stopping remifentanil [ Time Frame: 2.5 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Spinal Ketorolac After Acute Opioid Exposure
Official Title  ICMJE Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ketorolac
    single intrathecal injection of ketorolac 2 mg
    Other Names:
    • toradol
    • acular pf
  • Drug: placebo
    subject will receive a placebo (preservative free normal saline) spinal injection
  • Drug: remifentanil
    All subjects will receive a remifentanil infusion
    Other Name: ultiva
  • Drug: Capsaicin
    Topical capsaicin pain model utilized for each subject
Study Arms  ICMJE
  • Experimental: Intrathecal Ketorolac
    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.
    Interventions:
    • Drug: ketorolac
    • Drug: remifentanil
    • Drug: Capsaicin
  • Placebo Comparator: Placebo intrathecal injection
    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.
    Interventions:
    • Drug: placebo
    • Drug: remifentanil
    • Drug: Capsaicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
50
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693160
Other Study ID Numbers  ICMJE IRB00002457
GM48085
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE National Institute of General Medical Sciences (NIGMS)
Investigators  ICMJE
Principal Investigator: James C. Eisenach, M.D. Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP