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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