Trial Outcomes & Findings for Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia (NCT NCT01430182)
NCT ID: NCT01430182
Last Updated: 2016-04-04
Results Overview
Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
First 24 hours after discharge from Post-Anesthesia Care Unit
Results posted on
2016-04-04
Participant Flow
Subjects were inpatients in Ben Taub General Hospital, a General and Teaching Hospital in Houston, Texas. Subjects were enrolled from October 2011 through May 2013.
18 subjects were approached for participation. 1 was a screen failure, yielding 17 subjects who were randomized and received methadone or morphine
Participant milestones
| Measure |
Methadone 0.2 mg/kg
0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
Morphine 0.2 mg/kg
0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia
Baseline characteristics by cohort
| Measure |
Methadone 0.2 mg/kg
n=9 Participants
0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
Morphine 0.2 mg/kg
n=8 Participants
0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 7.4 • n=39 Participants
|
29.3 years
STANDARD_DEVIATION 10.2 • n=41 Participants
|
30.7 years
STANDARD_DEVIATION 8.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=39 Participants
|
8 participants
n=41 Participants
|
17 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: First 24 hours after discharge from Post-Anesthesia Care UnitNumber of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit
Outcome measures
| Measure |
Methadone 0.2 mg/kg
n=9 Participants
0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
Morphine 0.2 mg/kg
n=8 Participants
0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
|---|---|---|
|
Opioid Consumption
|
50.9 mg of morphine IV equivalents
Standard Deviation 38.7
|
37.5 mg of morphine IV equivalents
Standard Deviation 15.4
|
Adverse Events
Methadone 0.2 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Morphine 0.2 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methadone 0.2 mg/kg
n=9 participants at risk
0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
Morphine 0.2 mg/kg
n=8 participants at risk
0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
|
|---|---|---|
|
General disorders
Excessive sedation or excessive somnolence
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place