Trial Outcomes & Findings for A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery (NCT NCT02206685)
NCT ID: NCT02206685
Last Updated: 2021-02-16
Results Overview
Subjects were given access to Patient-Controlled Intravenous Opioid Administration (PCA) to manage their post-operative pain. The doses of morphine were calculated at at PACU, 24 hours, 48 hours and 72 hours respectively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
Admission to PACU to 72 hours post-operative
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
Treatment Group
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Treatment Group
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
|---|---|---|
|
Overall Study
Surgery cancelled/changed
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=32 Participants
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
n=30 Participants
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.09 years
STANDARD_DEVIATION 1.69 • n=32 Participants
|
14.33 years
STANDARD_DEVIATION 1.69 • n=30 Participants
|
14.21 years
STANDARD_DEVIATION 1.67 • n=62 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=32 Participants
|
22 Participants
n=30 Participants
|
48 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=32 Participants
|
8 Participants
n=30 Participants
|
14 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
30 participants
n=30 Participants
|
62 participants
n=62 Participants
|
|
Weight
|
58.26 kg
STANDARD_DEVIATION 12.72 • n=32 Participants
|
53.95 kg
STANDARD_DEVIATION 13.20 • n=30 Participants
|
56.18 kg
STANDARD_DEVIATION 12.92 • n=62 Participants
|
|
Height
|
160.64 cm
STANDARD_DEVIATION 9.98 • n=32 Participants
|
162.48 cm
STANDARD_DEVIATION 8.07 • n=30 Participants
|
161.53 cm
STANDARD_DEVIATION 9.01 • n=62 Participants
|
|
Body Mass Index
|
22.45 kg/m^2
STANDARD_DEVIATION 3.78 • n=32 Participants
|
20.29 kg/m^2
STANDARD_DEVIATION 3.89 • n=30 Participants
|
21.41 kg/m^2
STANDARD_DEVIATION 3.92 • n=62 Participants
|
|
ASA Status
I
|
7 Participants
n=32 Participants
|
3 Participants
n=30 Participants
|
10 Participants
n=62 Participants
|
|
ASA Status
II
|
22 Participants
n=32 Participants
|
27 Participants
n=30 Participants
|
49 Participants
n=62 Participants
|
|
ASA Status
III
|
3 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Admission to PACU to 72 hours post-operativeSubjects were given access to Patient-Controlled Intravenous Opioid Administration (PCA) to manage their post-operative pain. The doses of morphine were calculated at at PACU, 24 hours, 48 hours and 72 hours respectively.
Outcome measures
| Measure |
Treatment Group
n=32 Participants
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
n=30 Participants
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
|---|---|---|
|
Opioid Usage
PACU
|
0.41 mg/kg
Interval 0.25 to 0.65
|
0.47 mg/kg
Interval 0.33 to 0.62
|
|
Opioid Usage
24 Hours
|
0.58 mg/kg
Interval 0.34 to 0.82
|
0.55 mg/kg
Interval 0.37 to 0.66
|
|
Opioid Usage
48 Hours
|
0.58 mg/kg
Interval 0.31 to 0.79
|
0.55 mg/kg
Interval 0.24 to 0.65
|
|
Opioid Usage
72 Hours
|
0.10 mg/kg
Interval 0.0 to 0.23
|
0.04 mg/kg
Interval 0.0 to 0.14
|
SECONDARY outcome
Timeframe: Admission to PACU to 72 hours post-operativeThe FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The data reported here represents the mean difference in FLACC score by treatment group at PACU, 24 hours, 48 hours and 72 hours, respectively.
Outcome measures
| Measure |
Treatment Group
n=32 Participants
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
n=30 Participants
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
|---|---|---|
|
Pain Scores
PACU
|
0.53 units on a scale
Standard Deviation 0.76
|
0.65 units on a scale
Standard Deviation 0.70
|
|
Pain Scores
24 Hours
|
0.14 units on a scale
Standard Deviation 0.4
|
0.42 units on a scale
Standard Deviation 0.66
|
|
Pain Scores
48 Hours
|
0.24 units on a scale
Standard Deviation 0.45
|
0.36 units on a scale
Standard Deviation 0.62
|
|
Pain Scores
72 Hours
|
0.16 units on a scale
Standard Deviation 0.18
|
0.29 units on a scale
Standard Deviation 0.64
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=32 participants at risk
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
|
Control Group
n=30 participants at risk
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
46.9%
15/32 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
46.7%
14/30 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
10.0%
3/30 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia (oxygen required)
|
15.6%
5/32 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
0.00%
0/30 • At any time during hospitalization (Days 0 to 5)
Side effects of Methadone versus Placebo group were assessed during the duration of the subject's hospitalization. Incidents were counted once per subject.
|
Additional Information
Kim P. Nguyen, MD, Principal Investigator
Baylor College of Medicine
Phone: 832-824-5907
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place