Trial Outcomes & Findings for The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy (NCT NCT02252432)
NCT ID: NCT02252432
Last Updated: 2024-02-29
Results Overview
Perioperative use of opioid consumption inside the hospital (recorded by study staff and data obtained from patient charts)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
1 day
Results posted on
2024-02-29
Participant Flow
Participant milestones
| Measure |
Ketamine
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
2
|
|
Overall Study
COMPLETED
|
5
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Baseline characteristics by cohort
| Measure |
Ketamine
n=5 Participants
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
n=6 Participants
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
n=2 Participants
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayPerioperative use of opioid consumption inside the hospital (recorded by study staff and data obtained from patient charts)
Outcome measures
| Measure |
Ketamine
n=5 Participants
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
n=6 Participants
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
n=2 Participants
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
|---|---|---|---|
|
Opioid Consumption Obtained From the Recorded Data
|
23 milligram morphine equivalents
Standard Deviation 20
|
30 milligram morphine equivalents
Standard Deviation 16
|
26 milligram morphine equivalents
Standard Deviation 40
|
PRIMARY outcome
Timeframe: 1 dayPostoperative pain was measured at PACU using a Verbal Rating Scale from 0 to 10. Where 0= no pain and 10= maximum pain experienced
Outcome measures
| Measure |
Ketamine
n=5 Participants
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
n=6 Participants
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
n=2 Participants
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
|---|---|---|---|
|
Postoperative Pain
|
3.3 score on a scale
Standard Deviation 2
|
4.1 score on a scale
Standard Deviation 1
|
4.0 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1 dayThe number of participants who experienced nausea and vomiting
Outcome measures
| Measure |
Ketamine
n=5 Participants
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
n=6 Participants
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
n=2 Participants
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
|---|---|---|---|
|
Nausea and Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 daysDay one, day three after surgery
Outcome measures
| Measure |
Ketamine
n=5 Participants
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Methadone
n=6 Participants
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Ketamine + methadone: Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
|
Ketamine + Methadone
n=2 Participants
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Ketamine: A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
Methadone: A single dose of IV methadone (0.2 mg/kg) preinduction.
|
|---|---|---|---|
|
Number of Participants With Constipation at Follow up
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine + Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ofelia Loani Elvir Lazo, MD
Cedars Sinai Medical Center
Phone: 310-423-1682
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place