Trial Outcomes & Findings for Methadone in Pediatric Anesthesia (NCT NCT00921843)
NCT ID: NCT00921843
Last Updated: 2019-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
96 hr
Results posted on
2019-05-14
Participant Flow
Participant milestones
| Measure |
Methadone 0.1mg/kg
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.2mg/kg
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.3mg/kg
Subjects will receive methadone as their intraoperative opioid.
|
Control
Subjects do not receive methadone as their intraoperative opioid.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
30
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methadone 0.1mg/kg
n=10 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.2mg/kg
n=10 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.3mg/kg
n=11 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Control
n=30 Participants
Subjects do not receive methadone as their intraoperative opioid.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
30 Participants
n=30 Participants
|
61 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
21 Participants
n=30 Participants
|
42 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
9 Participants
n=30 Participants
|
19 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
30 Participants
n=30 Participants
|
61 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 96 hrOutcome measures
| Measure |
Methadone 0.1mg/kg
n=10 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.2mg/kg
n=10 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Methadone 0.3mg/kg
n=11 Participants
Subjects will receive methadone as their intraoperative opioid.
|
Control
n=30 Participants
Subjects do not receive methadone as their intraoperative opioid.
|
|---|---|---|---|---|
|
R-methadone Plasma AUC 0-96hr/Dose
|
228 (ng * hr-1 * ml-1 * mg-1
Standard Deviation 164
|
189 (ng * hr-1 * ml-1 * mg-1
Standard Deviation 54
|
205 (ng * hr-1 * ml-1 * mg-1
Standard Deviation 102
|
0 (ng * hr-1 * ml-1 * mg-1
Standard Deviation 0
|
Adverse Events
Methadone 0.1mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methadone 0.2mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methadone 0.3g/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place