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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177862
• Other study ID #: ANES-2019-28303
• Status: Completed
• Phase: Phase 4
• Start date: December 11, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Pain
• Pain, Acute

Intervention

Drug:
• Sublingual Sufentanil
30 mcg of sublingual sufentanil
• IV Fentanyl
50 mcg of IV fentanyl

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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