Phase 4
N=75
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Pain · Pain, Acute · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04177862 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Recovery Room Time — 73.0; 65.0 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sublingual Sufentanil (Drug); IV Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Room Time |
73.0; 65.0 | — |
| SECONDARY Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) |
15.0; 22.5 | — |
| SECONDARY Adverse Events |
0; 0 | — |
| SECONDARY Postoperative Nausea and Vomiting (PONV) |
4; 7 | — |
| SECONDARY Supplemental Oxygen |
4; 4 | — |
| SECONDARY Overall Benefit of Analgesic Score (OBAS) |
3.0; 3.0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04177862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.