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

Phase 4

Completed

• Conditions: Pain; Pain, Acute; Anesthesia
• Interventions: Drug: Sublingual Sufentanil; Drug: IV Fentanyl

• Registration Number: NCT04177862
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2019-12-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Results First Submitted: 2021-01-12
• Results First Submitted QC: 2021-01-12
• Results First Posted: 2021-02-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• undergoing outpatient ambulatory surgery
• recipient of general anesthesia
• pain score of 4 or greater in the PACU

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Sufentanil	Sublingual Sufentanil	Single dose of sublingual sufentanil for acute pain.
IV Fentanyl	IV Fentanyl	single dose of IV fentanyl for acute pain.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Adverse Events	1 day	Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Postoperative Nausea and Vomiting (PONV)	1 day	Number of participants in each arm who are treated for nausea and/or vomiting.
Supplemental Oxygen	1 day	Number of participants in each arm who require supplemental oxygen therapy
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States