Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT04177862
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 44.8

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.

Condition or Disease	Intervention/Treatment	Phase
Pain; Pain, Acute; Anesthesia	Drug: Sublingual Sufentanil; Drug: IV Fentanyl	Phase 4

Detailed Description

This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
• Actual Study Start Date: Dec 11, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sublingual Sufentanil Single dose of sublingual sufentanil for acute pain.	Drug: Sublingual Sufentanil; 30 mcg of sublingual sufentanil
Active Comparator: IV Fentanyl single dose of IV fentanyl for acute pain.	Drug: IV Fentanyl; 50 mcg of IV fentanyl

Outcome Measures

Primary Outcome Measures

1. Recovery Room Time [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.

Secondary Outcome Measures

1. Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) [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.

2. Adverse Events [1 day]

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

3. Postoperative Nausea and Vomiting (PONV) [1 day]

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

4. Supplemental Oxygen [1 day]

   Number of participants in each arm who require supplemental oxygen therapy

5. Overall Benefit of Analgesic Score (OBAS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• undergoing outpatient ambulatory surgery

• recipient of general anesthesia

• pain score of 4 or greater in the PACU

Exclusion Criteria:

• non-english speaking patients

• cancer surgeries

• patients who have allergy or intolerance to the study drugs or derivatives

• patients on chronic opioids (defined as daily opioids for 3 months or longer)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Aaron M Berg, MD, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2019

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04177862
• Other Study ID Numbers: ANES-2019-28303
• First Posted: Nov 26, 2019
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Acute Pain; Fentanyl; Sufentanil

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Period Title: Overall Study
STARTED	35	40
COMPLETED	33	33
NOT COMPLETED	2	7

Baseline Characteristics

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl	Total
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl	Total of all reporting groups
Overall Participants	35	40	75
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	52	37	42
Sex: Female, Male (Count of Participants)
Female	22 62.9%	24 60%	46 61.3%
Male	13 37.1%	16 40%	29 38.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%	40 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Recovery Room Time
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Median (Inter-Quartile Range) [minutes]	73.0	65.0

2. Secondary Outcome

Title	Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Median (Inter-Quartile Range) [milligram morphine equivalents]	15.0	22.5

3. Secondary Outcome

Title	Adverse Events
Description	Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Number [SAEs]	0	0

4. Secondary Outcome

Title	Postoperative Nausea and Vomiting (PONV)
Description	Number of participants in each arm who are treated for nausea and/or vomiting.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg of sublingual sufentanil	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Count of Participants [Participants]	4 11.4%	7 17.5%

5. Secondary Outcome

Title	Supplemental Oxygen
Description	Number of participants in each arm who require supplemental oxygen therapy
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Count of Participants [Participants]	4 11.4%	4 10%

6. Secondary Outcome

Title	Overall Benefit of Analgesic Score (OBAS)
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sublingual Sufentanil	IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet	single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
Measure Participants	35	40
Median (Inter-Quartile Range) [score on a scale]	3.0	3.0

Adverse Events

Time Frame	1 day
Arm/Group Title	Sublingual Sufentanil		IV Fentanyl
Arm/Group Description	Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet		single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl
All Cause Mortality
	Sublingual Sufentanil		IV Fentanyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/40 (0%)
Serious Adverse Events
	Sublingual Sufentanil		IV Fentanyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Sublingual Sufentanil		IV Fentanyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/35 (11.4%)		7/40 (17.5%)
Surgical and medical procedures
Postoperative nausea	4/35 (11.4%)	4	7/40 (17.5%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.