Trial Outcomes & Findings for Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center (NCT NCT04177862)

Results Overview

The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

1 day

Results posted on

2021-04-19

Participant Flow

Participants were assigned to groups after undergoing their surgical procedures if they had a self-reported pain score of 4 and above on the 11-point numeric rating scale during phase 1 of PACU.

Participant milestones

Participant milestones
Measure	Sublingual Sufentanil Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Overall Study STARTED	35	40
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sublingual Sufentanil Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Overall Study Protocol Violation	2	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl	Total n=75 Participants Total of all reporting groups
Age, Continuous	52 years n=35 Participants	37 years n=40 Participants	42 years n=75 Participants
Sex: Female, Male Female	22 Participants n=35 Participants	24 Participants n=40 Participants	46 Participants n=75 Participants
Sex: Female, Male Male	13 Participants n=35 Participants	16 Participants n=40 Participants	29 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	35 participants n=35 Participants	40 participants n=40 Participants	75 participants n=75 Participants

PRIMARY outcome

Timeframe: 1 day

The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.

Outcome measures

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Recovery Room Time	73.0 minutes Interval 56.0 to 89.0	65.0 minutes Interval 56.0 to 89.0

SECONDARY outcome

Timeframe: 1 day

All doses of opioid medications administered following initial dosage (sufentanil or fentanyl depending on study arm) will be converted to milligram morphine equivalents and summed for reporting.

Outcome measures

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)	15.0 milligram morphine equivalents Interval 7.5 to 30.0	22.5 milligram morphine equivalents Interval 13.1 to 23.4

SECONDARY outcome

Timeframe: 1 day

Number of serious adverse events (grades 3, 4, and 5) experienced by each group

Outcome measures

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Adverse Events	0 SAEs	0 SAEs

SECONDARY outcome

Timeframe: 1 day

Number of participants in each arm who are treated for nausea and/or vomiting.

Outcome measures

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Postoperative Nausea and Vomiting (PONV)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 day

Number of participants in each arm who require supplemental oxygen therapy

Outcome measures

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Supplemental Oxygen	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures
Measure	Sublingual Sufentanil n=35 Participants Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 Participants single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Overall Benefit of Analgesic Score (OBAS)	3.0 score on a scale Interval 2.0 to 4.0	3.0 score on a scale Interval 1.0 to 4.5

Adverse Events

Sublingual Sufentanil

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

IV Fentanyl

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sublingual Sufentanil n=35 participants at risk Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	IV Fentanyl n=40 participants at risk single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Surgical and medical procedures Postoperative nausea	11.4% 4/35 • Number of events 4 • 1 day	17.5% 7/40 • Number of events 7 • 1 day

Additional Information

Dr. Jonah Pearson

University of Minnesota

Phone: 218-280-8348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place