Trial Outcomes & Findings for Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center (NCT NCT04387136)

NCT ID: NCT04387136

Last Updated: 2022-06-28

Results Overview

Pain is assessed on a scale of 0-10 (whole numbers). A score of 0 being no pain, 10 being maximum imaginable pain. Data collected upon arrival to Post-Anesthesia Care Unit (PACU).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2022-06-28

Participant Flow

Participant milestones

Measure	Sublingual Sufentanil Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control Participants in this arm will not receive an intervention.
Overall Study STARTED	26	27
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Sublingual Sufentanil Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control Participants in this arm will not receive an intervention.
Overall Study Protocol Deviation by SOC staff	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sublingual Sufentanil n=26 Participants Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control n=27 Participants Participants in this arm will not receive an intervention.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=26 Participants	0 Participants n=27 Participants	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=26 Participants	26 Participants n=27 Participants	50 Participants n=53 Participants
Age, Categorical >=65 years	2 Participants n=26 Participants	1 Participants n=27 Participants	3 Participants n=53 Participants
Sex: Female, Male Female	12 Participants n=26 Participants	9 Participants n=27 Participants	21 Participants n=53 Participants
Sex: Female, Male Male	14 Participants n=26 Participants	18 Participants n=27 Participants	32 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 hours

Pain is assessed on a scale of 0-10 (whole numbers). A score of 0 being no pain, 10 being maximum imaginable pain. Data collected upon arrival to Post-Anesthesia Care Unit (PACU).

Outcome measures

Measure	Sublingual Sufentanil n=25 Participants Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control n=25 Participants Participants in this arm will not receive an intervention.
Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival	4 score on a scale Interval 0.0 to 6.0	4 score on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 2 hours

Opioid medication type and dose will be recorded and converted to milligram morphine equivalents. Outcome is reported as the total milligram morphine equivalents of opioid medication used in the recovery room.

Outcome measures

Measure	Sublingual Sufentanil n=25 Participants Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control n=25 Participants Participants in this arm will not receive an intervention.
Opioid Use in Recovery Room	7.5 mg (morphine equivalent) Interval 0.0 to 22.5	15.0 mg (morphine equivalent) Interval 7.5 to 37.5

SECONDARY outcome

Timeframe: 2 hours

Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.

Outcome measures

Measure	Sublingual Sufentanil n=25 Participants Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control n=25 Participants Participants in this arm will not receive an intervention.
OBAS Score	1.0 score Interval 0.0 to 2.0	3.0 score Interval 1.0 to 3.0

Adverse Events

Sublingual Sufentanil

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sublingual Sufentanil n=25 participants at risk Participants in this arm will receive the intervention. Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.	Control n=25 participants at risk Participants in this arm will not receive an intervention.
Psychiatric disorders Anxiety	8.0% 2/25 • Number of events 3 • 16 weeks from baseline	4.0% 1/25 • Number of events 1 • 16 weeks from baseline
Gastrointestinal disorders Emesis	4.0% 1/25 • Number of events 1 • 16 weeks from baseline	0.00% 0/25 • 16 weeks from baseline
Gastrointestinal disorders Post-operative nausea and vomiting	4.0% 1/25 • Number of events 1 • 16 weeks from baseline	0.00% 0/25 • 16 weeks from baseline

Additional Information

Aaron Berg

University of Minnesota

Phone: 612-625-7675

Email: bergx831@umn.edu

Results disclosure agreements

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