NCT04177862

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Pain, Acute
• Anesthesia

Interventions

Type	Name	Description
DRUG	Sublingual Sufentanil	30 mcg of sublingual sufentanil
DRUG	IV Fentanyl	50 mcg of IV fentanyl

Timeline

• Start date: 2019-12-11
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-11-26
• Last updated: 2021-04-19
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study