Trial Outcomes & Findings for Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) (NCT NCT03726268)

Last Updated: 2025-11-19

Results Overview

Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

907 participants

Primary outcome timeframe

Approximately 30 days

Results posted on

2025-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Short-stay, IV Methadone Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Overall Study STARTED	188	188	205	205
Overall Study COMPLETED	175	175	190	194
Overall Study NOT COMPLETED	13	13	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Short-stay, IV Methadone Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Overall Study Physician Decision	2	8	6	3
Overall Study Withdrawal by Subject	11	5	9	8

Baseline Characteristics

Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short-stay, IV Methadone n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=190 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=194 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Total n=734 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 13.4	41.6 years STANDARD_DEVIATION 13.4 • n=4 Participants	44.6 years STANDARD_DEVIATION 12.3 • n=8 Participants	43.6 years STANDARD_DEVIATION 12.0 • n=19 Participants	43.0 years STANDARD_DEVIATION 12.8 • n=526 Participants
Sex: Female, Male Female	84 Participants	97 Participants n=4 Participants	154 Participants n=8 Participants	142 Participants n=19 Participants	477 Participants n=526 Participants
Sex: Female, Male Male	91 Participants	78 Participants n=4 Participants	36 Participants n=8 Participants	52 Participants n=19 Participants	257 Participants n=526 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	4 Participants n=4 Participants	7 Participants n=8 Participants	8 Participants n=19 Participants	25 Participants n=526 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants	164 Participants n=4 Participants	171 Participants n=8 Participants	173 Participants n=19 Participants	669 Participants n=526 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants	7 Participants n=4 Participants	12 Participants n=8 Participants	13 Participants n=19 Participants	40 Participants n=526 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants	3 Participants n=4 Participants	3 Participants n=8 Participants	2 Participants n=19 Participants	8 Participants n=526 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants	4 Participants n=4 Participants	1 Participants n=8 Participants	5 Participants n=19 Participants	12 Participants n=526 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants
Race/Ethnicity, Customized Race · Black or African American	39 Participants	30 Participants n=4 Participants	35 Participants n=8 Participants	18 Participants n=19 Participants	122 Participants n=526 Participants
Race/Ethnicity, Customized Race · White	124 Participants	131 Participants n=4 Participants	140 Participants n=8 Participants	164 Participants n=19 Participants	559 Participants n=526 Participants
Race/Ethnicity, Customized Race · More than one race	2 Participants	0 Participants n=4 Participants	4 Participants n=8 Participants	1 Participants n=19 Participants	7 Participants n=526 Participants
Race/Ethnicity, Customized Race · Other	2 Participants	2 Participants n=4 Participants	4 Participants n=8 Participants	1 Participants n=19 Participants	9 Participants n=526 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	6 Participants	5 Participants n=4 Participants	3 Participants n=8 Participants	3 Participants n=19 Participants	17 Participants n=526 Participants
Region of Enrollment United States	175 Participants	175 Participants n=4 Participants	190 Participants n=8 Participants	194 Participants n=19 Participants	734 Participants n=526 Participants

PRIMARY outcome

Timeframe: Approximately 30 days

Outcome measures

Outcome measures
Measure	Short-stay, IV Methadone n=147 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=140 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=167 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=161 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)	10.00 tablets Standard Deviation 15.50	10.00 tablets Standard Deviation 11.60	6.18 tablets Standard Deviation 8.40	6.67 tablets Standard Deviation 10.40

SECONDARY outcome

Timeframe: Approximately 12 hours

Based on hospital record.

Outcome measures

Outcome measures
Measure	Short-stay, IV Methadone n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=190 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=194 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Total Intraoperative Non-methadone Opioid Administration	0.0 Milligram Morphine Equivalent (MME) Interval 0.0 to 0.0	18.0 Milligram Morphine Equivalent (MME) Interval 14.0 to 23.0	0.0 Milligram Morphine Equivalent (MME) Interval 0.0 to 0.0	16.7 Milligram Morphine Equivalent (MME) Interval 12.7 to 24.0

SECONDARY outcome

Timeframe: Approximately 2 hours

Based on hospital record.

Outcome measures

Outcome measures
Measure	Short-stay, IV Methadone n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=190 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=194 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Total Post Anesthesia Care Unit (PACU) Opioid Administration	2.0 Milligram Morphine Equivalent (MME) Interval 0.0 to 4.0	3.0 Milligram Morphine Equivalent (MME) Interval 0.0 to 7.0	2.0 Milligram Morphine Equivalent (MME) Interval 0.0 to 4.0	2.5 Milligram Morphine Equivalent (MME) Interval 0.0 to 6.7

SECONDARY outcome

Timeframe: Start of surgery to hospital discharge, up to 2 days

Based on hospital record.

Outcome measures

Outcome measures
Measure	Short-stay, IV Methadone n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=175 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=190 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=194 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Total Hospital Non-methadone Opioid Administration	30 Milligram Morphine Equivalent (MME) Interval 0.0 to 80.0	128 Milligram Morphine Equivalent (MME) Interval 85.0 to 185.0	0 Milligram Morphine Equivalent (MME) Interval 0.0 to 15.0	68 Milligram Morphine Equivalent (MME) Interval 50.0 to 97.0

SECONDARY outcome

Timeframe: Up to 7 days post-PACU discharge

Population: Participants with data collected.

Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects.

Outcome measures

Outcome measures
Measure	Short-stay, IV Methadone n=154 Participants Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=151 Participants Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=175 Participants Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=173 Participants Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Total 7-day Post-PACU Discharge Home Opioid Use	6.50 tablets Standard Deviation 8.10	8.20 tablets Standard Deviation 8.70	4.96 tablets Standard Deviation 5.80	5.45 tablets Standard Deviation 7.20

Adverse Events

Short-stay, IV Methadone

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Short-stay, IV Short-acting Opioids

Serious events: 6 serious events

Other events: 17 other events

Deaths: 1 deaths

Same-day, IV Methadone

Serious events: 10 serious events

Other events: 29 other events

Deaths: 0 deaths

Same-day, IV Short-acting Opioids

Serious events: 11 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Evan Kharasch, MD, PhD

Duke University

Phone: 919-613-1154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Short-stay, IV Methadone n=188 participants at risk Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Short-stay, IV Short-acting Opioids n=188 participants at risk Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).	Same-day, IV Methadone n=205 participants at risk Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.	Same-day, IV Short-acting Opioids n=205 participants at risk Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Psychiatric disorders admission to behavioral facility	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Gastrointestinal disorders anastomotic leak	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Gastrointestinal disorders appendicitis	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Renal and urinary disorders bladder spasms	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Injury, poisoning and procedural complications bleeding	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Gastrointestinal disorders bleeding ulcer	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Injury, poisoning and procedural complications carbon monoxide poisoning	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Immune system disorders febrile neutropenia	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
General disorders fever	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Gastrointestinal disorders colovesicular fistula	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Gastrointestinal disorders ileus	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Nervous system disorders seizures	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Infections and infestations sepsis	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Renal and urinary disorders urinary retention	0.53% 1/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Infections and infestations urosepsis	0.00% 0/188 • Approximately 30 days	0.53% 1/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Infections and infestations Cellulitis	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Injury, poisoning and procedural complications Epistaxis	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Infections and infestations Infection	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Cardiac disorders NSTEMI	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Injury, poisoning and procedural complications Post-operative Hemorrhage	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Injury, poisoning and procedural complications Vagal response to laryngoscopy	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
Infections and infestations Wound Infection	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Pregnancy, puerperium and perinatal conditions cesarean delivery	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Blood and lymphatic system disorders hemorrhagic cyst	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastasis	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days
General disorders pain	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.00% 0/205 • Approximately 30 days	0.49% 1/205 • Approximately 30 days
Pregnancy, puerperium and perinatal conditions spontaneous labor	0.00% 0/188 • Approximately 30 days	0.00% 0/188 • Approximately 30 days	0.49% 1/205 • Approximately 30 days	0.00% 0/205 • Approximately 30 days