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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Acute; Anesthesia
• Intervention / Treatment: Drug: Sublingual Sufentanil; Drug: IV Fentanyl

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Sufentanil
• Other Study ID Numbers: ANES-2019-28303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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