Trial Outcomes & Findings for Methadone in Ambulatory Surgery (NCT NCT02300077)
NCT ID: NCT02300077
Last Updated: 2019-05-17
Results Overview
Data on opioids administered intraoperatively will be collected from the subject's EMR.
COMPLETED
NA
60 participants
Administered at induction of anesthesia
2019-05-17
Participant Flow
Recruitment was done between March 2015-May 2016.
We withdrew 4 patients after consenting - two of patients met exclusion criteria, one patient withdrew consent, one anesthesia provider refused to participate the study.
Participant milestones
| Measure |
Control
Control (Intra-operative administration of opioids, other than methadone)
|
Treatment Methadone 0.1 mg/kg
methadone
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
methadone
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
21
|
|
Overall Study
COMPLETED
|
21
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methadone in Ambulatory Surgery
Baseline characteristics by cohort
| Measure |
Control
n=21 Participants
Control (Intra-operative administration of opioids, other than methadone)
Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone
|
Treatment Methadone 0.1 mg/kg
n=18 Participants
methadone 0.1 mg/kg
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
n=21 Participants
methadone: Escalating dose of methadone up to .3mg/kg.
|
Total
n=60 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
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 13 • n=39 Participants
|
37 years
STANDARD_DEVIATION 11 • n=41 Participants
|
40 years
STANDARD_DEVIATION 11 • n=35 Participants
|
40 years
STANDARD_DEVIATION 2.52 • n=31 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
55 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
40 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
18 participants
n=41 Participants
|
21 participants
n=35 Participants
|
60 participants
n=31 Participants
|
|
body weight - kg
|
85 Kg
STANDARD_DEVIATION 16 • n=39 Participants
|
88 Kg
STANDARD_DEVIATION 42 • n=41 Participants
|
86 Kg
STANDARD_DEVIATION 26 • n=35 Participants
|
86 Kg
STANDARD_DEVIATION 1.53 • n=31 Participants
|
|
ASA status
ASA I
|
1 units on a scale
n=39 Participants
|
0 units on a scale
n=41 Participants
|
0 units on a scale
n=35 Participants
|
1 units on a scale
n=31 Participants
|
|
ASA status
ASA II
|
16 units on a scale
n=39 Participants
|
17 units on a scale
n=41 Participants
|
21 units on a scale
n=35 Participants
|
54 units on a scale
n=31 Participants
|
|
ASA status
ASA III
|
4 units on a scale
n=39 Participants
|
1 units on a scale
n=41 Participants
|
0 units on a scale
n=35 Participants
|
5 units on a scale
n=31 Participants
|
PRIMARY outcome
Timeframe: Administered at induction of anesthesiaData on opioids administered intraoperatively will be collected from the subject's EMR.
Outcome measures
| Measure |
Control
n=21 Participants
Control (Intra-operative administration of opioids, other than methadone)
Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone
|
Treatment Methadone 0.1 mg/kg
n=18 Participants
methadone 0.1 mg/kg
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
n=21 Participants
methadone: Escalating dose of methadone up to .3mg/kg.
|
|---|---|---|---|
|
Intraoperative Opioid Administration
|
25 morphine equivalents mg
Interval 23.3 to 28.3
|
5.6 morphine equivalents mg
Interval 5.0 to 6.0
|
8.6 morphine equivalents mg
Interval 7.8 to 9.0
|
PRIMARY outcome
Timeframe: EMR reviewed at 24 hours post-administration or at hospital dischargeData on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale \[0-no relief, 4-complete relief\]
Outcome measures
| Measure |
Control
n=21 Participants
Control (Intra-operative administration of opioids, other than methadone)
Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone
|
Treatment Methadone 0.1 mg/kg
n=18 Participants
methadone 0.1 mg/kg
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
n=21 Participants
methadone: Escalating dose of methadone up to .3mg/kg.
|
|---|---|---|---|
|
Postoperative Opioid Administration
|
10 morphine equivalents mg
Interval 2.5 to 14.3
|
5.4 morphine equivalents mg
Interval 3.3 to 9.6
|
3.3 morphine equivalents mg
Interval 0.1 to 5.8
|
SECONDARY outcome
Timeframe: 30 daysDaily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
Outcome measures
| Measure |
Control
n=21 Participants
Control (Intra-operative administration of opioids, other than methadone)
Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone
|
Treatment Methadone 0.1 mg/kg
n=18 Participants
methadone 0.1 mg/kg
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
n=21 Participants
methadone: Escalating dose of methadone up to .3mg/kg.
|
|---|---|---|---|
|
Opioid Consumption Within First 30 Postoperative Days
|
10 total postdischarge opioid pills used
Interval 3.0 to 20.0
|
7 total postdischarge opioid pills used
Interval 4.0 to 19.0
|
5 total postdischarge opioid pills used
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: 30 daysDaily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient's 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.
Outcome measures
| Measure |
Control
n=12 Participants
Control (Intra-operative administration of opioids, other than methadone)
Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone
|
Treatment Methadone 0.1 mg/kg
n=14 Participants
methadone 0.1 mg/kg
methadone: Escalating dose of methadone up to .3mg/kg.
|
Treatment Methadone 0.15 mg/kg
n=14 Participants
methadone: Escalating dose of methadone up to .3mg/kg.
|
|---|---|---|---|
|
Pain Relief Within First 30 Postoperative Days
|
1 score on a scale
Interval 0.0 to 5.0
|
1 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 2.0
|
Adverse Events
Control
Treatment Methadone 0.1 mg/kg
Treatment Methadone 0.15 mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Helga Komen
Department of Anesthesiology Washington University in St. Louis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place