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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: ketorolac
Drug: placebo
Drug: remifentanil
Drug: Capsaicin
Enrollment 30
Recruitment Details 31 healthy subjects between the ages of 19-51 were recruited and 30 were randomized between the dates for 11/20/2007 and 8/17/2010. Subjects were seen for all study related visits in the General Clinical Research Center at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.
Pre-assignment Details  
Arm/Group Title Intrathecal Ketorolac Placebo Intrathecal Injection
Hide Arm/Group Description

In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.

The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.

The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes.

In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).

The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.

The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes.

Period Title: Overall Study
Started 14 16
Completed 14 16
Not Completed 0 0
Arm/Group Title Intrathecal Ketorolac Placebo Intrathecal Injection Total
Hide Arm/Group Description In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Total of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
16
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 30 participants
31.78  (11.52) 32.06  (8.52) 31.93  (9.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Female
3
  21.4%
6
  37.5%
9
  30.0%
Male
11
  78.6%
10
  62.5%
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 16 participants 30 participants
14 16 30
1.Primary Outcome
Title Hyperalgesia
Hide Description 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
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intrathecal Ketorolac Placebo Intrathecal Injection
Hide Arm/Group Description:
In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: centimeters^2
70.1  (40.5) 48.4  (33.5)
2.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
Hide Description Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac
Time Frame 2.5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection.
Arm/Group Title Intrathecal Ketorolac Placebo Intrathecal Injection
Hide Arm/Group Description:
In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
Overall Number of Participants Analyzed 11 16
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
87  (95) 75  (41)
Time Frame 2 weeks
Adverse Event Reporting Description Subjects were followed up for 2 weeks and questioned for any adverse events
 
Arm/Group Title Intrathecal Ketorolac Placebo Intrathecal Injection
Hide Arm/Group Description In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
All-Cause Mortality
Intrathecal Ketorolac Placebo Intrathecal Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intrathecal Ketorolac Placebo Intrathecal Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intrathecal Ketorolac Placebo Intrathecal Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James C. Eisenach, M.D.
Organization: Wake Forest School of Medicine
Phone: 336-716-4498
EMail: jimeisenach@gmail.com
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00693160     History of Changes
Other Study ID Numbers: IRB00002457
GM48085
First Submitted: February 15, 2008
First Posted: June 6, 2008
Results First Submitted: May 15, 2013
Results First Posted: April 14, 2014
Last Update Posted: September 7, 2018