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

University of Minnesota (UMN)

Status and phase: Completed; Phase 4

Conditions: Pain, Acute; Pain; Anesthesia

Treatments: Drug: IV Fentanyl; Drug: Sublingual Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04177862

ANES-2019-28303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

75 participants in 2 patient groups

Sublingual Sufentanil

Experimental group

Description:

Single dose of sublingual sufentanil for acute pain.

Treatment:

Drug: Sublingual Sufentanil

IV Fentanyl

Active Comparator group

Description:

single dose of IV fentanyl for acute pain.

Treatment:

Drug: IV Fentanyl