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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Sublingual Sufentanil
    • Single dose of sublingual sufentanil for acute pain.
  • Active Comparator: IV Fentanyl
    • single dose of IV fentanyl for acute pain.

Clinical Trial Outcome Measures

Primary Measures

  • Recovery Room Time
    • Time Frame: 1 day
    • 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.

Secondary Measures

  • Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
    • Time Frame: 1 day
    • 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.
  • Adverse Events
    • Time Frame: 1 day
    • Number of serious adverse events (grades 3, 4, and 5) experienced by each group
  • Postoperative Nausea and Vomiting (PONV)
    • Time Frame: 1 day
    • Number of participants in each arm who are treated for nausea and/or vomiting.
  • Supplemental Oxygen
    • Time Frame: 1 day
    • Number of participants in each arm who require supplemental oxygen therapy
  • Overall Benefit of Analgesic Score (OBAS)
    • Time Frame: 1 day
    • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Minnesota
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aaron M Berg, MD, Principal Investigator, University of Minnesota

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