Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Primary Purpose
Pain, Pain, Acute, Anesthesia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sublingual Sufentanil
IV Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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)
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sublingual Sufentanil
IV Fentanyl
Arm Description
Single dose of sublingual sufentanil for acute pain.
single dose of IV fentanyl for acute pain.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
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.
Adverse Events
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Postoperative Nausea and Vomiting (PONV)
Number of participants in each arm who are treated for nausea and/or vomiting.
Supplemental Oxygen
Number of participants in each arm who require supplemental oxygen therapy
Overall Benefit of Analgesic Score (OBAS)
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.
Full Information
NCT ID
NCT04177862
First Posted
November 22, 2019
Last Updated
April 15, 2021
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04177862
Brief Title
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Official Title
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Acute, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Sufentanil
Arm Type
Experimental
Arm Description
Single dose of sublingual sufentanil for acute pain.
Arm Title
IV Fentanyl
Arm Type
Active Comparator
Arm Description
single dose of IV fentanyl for acute pain.
Intervention Type
Drug
Intervention Name(s)
Sublingual Sufentanil
Intervention Description
30 mcg of sublingual sufentanil
Intervention Type
Drug
Intervention Name(s)
IV Fentanyl
Intervention Description
50 mcg of IV fentanyl
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Title
Adverse Events
Description
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Time Frame
1 day
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
Title
Supplemental Oxygen
Description
Number of participants in each arm who require supplemental oxygen therapy
Time Frame
1 day
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron M Berg, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
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