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

University of Minnesota75 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Pain, Acute Anesthesia

Interventions

Sublingual SufentanilDRUG

30 mcg of sublingual sufentanil

IV FentanylDRUG

50 mcg of IV fentanyl

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 1 day

Adverse Events

Number of serious adverse events (grades 3, 4, and 5) experienced by each group

Time frame: 1 day

Postoperative Nausea and Vomiting (PONV)

Number of participants in each arm who are treated for nausea and/or vomiting.

Time frame: 1 day

Supplemental Oxygen

Number of participants in each arm who require supplemental oxygen therapy

Time frame: 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.

Time frame: 1 day

Data from ClinicalTrials.gov

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