Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Dec 2019
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedResults Posted
Study results publicly available
February 2, 2021
CompletedApril 19, 2021
April 1, 2021
2 months
November 22, 2019
January 12, 2021
April 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery Room Time
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.
1 day
Secondary Outcomes (5)
Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
1 day
Adverse Events
1 day
Postoperative Nausea and Vomiting (PONV)
1 day
Supplemental Oxygen
1 day
Overall Benefit of Analgesic Score (OBAS)
1 day
Study Arms (2)
Sublingual Sufentanil
EXPERIMENTALSingle dose of sublingual sufentanil for acute pain.
IV Fentanyl
ACTIVE COMPARATORsingle dose of IV fentanyl for acute pain.
Interventions
Eligibility Criteria
You may qualify if:
- undergoing outpatient ambulatory surgery
- recipient of general anesthesia
- pain score of 4 or greater in the PACU
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonah Pearson
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron M Berg, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2019
First Posted
November 26, 2019
Study Start
December 11, 2019
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
April 19, 2021
Results First Posted
February 2, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share