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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Administered at induction of anesthesia

Results posted on

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

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

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 anesthesia

Data on opioids administered intraoperatively will be collected from the subject's EMR.

Outcome measures

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 discharge

Data 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

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 days

Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).

Outcome measures

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 days

Daily 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Methadone 0.1 mg/kg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Methadone 0.15 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

Adverse event data not reported

Additional Information

Helga Komen

Department of Anesthesiology Washington University in St. Louis

Phone: 3148527622

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place