Trial Outcomes & Findings for Methadone in Pediatric Anesthesiology II (NCT NCT01990573)
NCT ID: NCT01990573
Last Updated: 2020-01-28
Results Overview
Measure of overall morphine consumption
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
6 days
Results posted on
2020-01-28
Participant Flow
53 signed consents however, 2 participants withdrew prior to randomization: 1 per family request 1 unable to complete
Participant milestones
| Measure |
Methadone HCl 0.3 mg/kg
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
14
|
17
|
|
Overall Study
COMPLETED
|
20
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Methadone HCl 0.3 mg/kg
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Methadone in Pediatric Anesthesiology II
Baseline characteristics by cohort
| Measure |
Methadone 0.3 mg/kg
n=20 Participants
0.3mg/kg IV methadone
0.3mg/kg IV methadone : Group I will receive 0.3mg/kg IV methadone
|
Methadone 0.4 mg/kg
n=14 Participants
0.4mg/kg IV methadone
0.4mg/kg IV methadone: Group II will receive 0.4mg/kg IV methadone .
|
Control Group
n=17 Participants
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.7 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
14.8 Years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
14.5 Years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.3 Years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Satus
ASA 1 -A normal healthy patient
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Satus
ASA 2 - A patient with mild systemic disease
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Pre-operative pain score
|
1.6 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
.6 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Expected Post-operative Pain Score
|
7.9 0-10 units on a Visual Analog scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
6.9 0-10 units on a Visual Analog scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.5 0-10 units on a Visual Analog scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.2 0-10 units on a Visual Analog scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
|
BMI
|
21.6 kg/m^2 scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
21.3 kg/m^2 scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
22.4 kg/m^2 scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
21.7 kg/m^2 scale
STANDARD_DEVIATION 3.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 daysMeasure of overall morphine consumption
Outcome measures
| Measure |
Methadone HCl 0.3 mg/kg
n=20 Participants
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
n=14 Participants
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
n=16 Participants
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Total Opioid Consumption (Morphine Equivalent)
|
2.22 mg/kg
Standard Deviation .84
|
2.37 mg/kg
Standard Deviation .86
|
3.28 mg/kg
Standard Deviation .93
|
PRIMARY outcome
Timeframe: 6 daysAssessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .
Outcome measures
| Measure |
Methadone HCl 0.3 mg/kg
n=20 Participants
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
n=14 Participants
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
n=16 Participants
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Pain Scores
|
4.7 score on a scale
Standard Deviation 2.4
|
4.6 score on a scale
Standard Deviation 2.9
|
4.5 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 96 hoursPopulation: Methadone clearance was only measured in the two groups that received methadone
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.
Outcome measures
| Measure |
Methadone HCl 0.3 mg/kg
n=20 Participants
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
n=14 Participants
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Cmax of R and S Methadone
R- Methadone
|
97 ng/ml
Standard Deviation 37
|
175 ng/ml
Standard Deviation 93
|
—
|
|
Cmax of R and S Methadone
S- Methadone
|
127 ng/ml
Standard Deviation 43
|
226 ng/ml
Standard Deviation 113
|
—
|
Adverse Events
Methadone HCl 0.3 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Methadone HCl 0.4 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methadone HCl 0.3 mg/kg
n=20 participants at risk
0.3mg/kg IV methadone HCl
0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl
|
Methadone HCl 0.4 mg/kg
n=14 participants at risk
0.4mg/kg IV methadon HCl
0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl.
|
Control Group
n=16 participants at risk
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|---|---|---|---|
|
Surgical and medical procedures
Excessive sedation
|
5.0%
1/20 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
0.00%
0/14 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
6.2%
1/16 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
20.0%
4/20 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
42.9%
6/14 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
43.8%
7/16 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
0.00%
0/14 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
0.00%
0/16 • Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
|
Additional Information
Dr. Anshuman Sharma
Washington University School of Medicine
Phone: 314-457-3147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place