Trial Outcomes & Findings for Effect of Spinal Ketorolac After Acute Opioid Exposure (NCT NCT00693160)
NCT ID: NCT00693160
Last Updated: 2018-09-07
Results Overview
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
TERMINATED
PHASE2
30 participants
24 hours
2018-09-07
Participant Flow
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.
Participant milestones
| Measure |
Intrathecal Ketorolac
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.
|
Placebo Intrathecal Injection
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Spinal Ketorolac After Acute Opioid Exposure
Baseline characteristics by cohort
| Measure |
Intrathecal Ketorolac
n=14 Participants
In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
|
Placebo Intrathecal Injection
n=16 Participants
In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
31.78 years
STANDARD_DEVIATION 11.52 • n=93 Participants
|
32.06 years
STANDARD_DEVIATION 8.52 • n=4 Participants
|
31.93 years
STANDARD_DEVIATION 9.86 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
16 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hoursTotal Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament
Outcome measures
| Measure |
Intrathecal Ketorolac
n=14 Participants
In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
|
Placebo Intrathecal Injection
n=16 Participants
In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
|
|---|---|---|
|
Hyperalgesia
|
70.1 centimeters^2
Standard Deviation 40.5
|
48.4 centimeters^2
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: 2.5 hoursPopulation: 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.
Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac
Outcome measures
| Measure |
Intrathecal Ketorolac
n=11 Participants
In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
|
Placebo Intrathecal Injection
n=16 Participants
In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
|
|---|---|---|
|
Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
|
87 picograms per milliliter
Standard Deviation 95
|
75 picograms per milliliter
Standard Deviation 41
|
Adverse Events
Intrathecal Ketorolac
Placebo Intrathecal Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place