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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Pain, Acute, Anesthesia

Intervention / Treatment
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* Drug: Sublingual Sufentanil
* Drug: IV Fentanyl


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Sufentanil<br>Single dose of sublingual sufentanil for acute pain. | Drug: Sublingual Sufentanil<br>* 30 mcg of sublingual sufentanil<br>|
| Active Comparator: IV Fentanyl<br>single dose of IV fentanyl for acute pain. | Drug: IV Fentanyl<br>* 50 mcg of IV fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| Adverse Events | Number of serious adverse events (grades 3, 4, and 5) experienced by each group | 1 day | 
| Postoperative Nausea and Vomiting (PONV) | Number of participants in each arm who are treated for nausea and/or vomiting. | 1 day | 
| Supplemental Oxygen | Number of participants in each arm who require supplemental oxygen therapy | 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. | 1 day |