Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
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|ClinicalTrials.gov Identifier: NCT04177862|
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Pain, Acute Anesthesia||Drug: Sublingual Sufentanil Drug: IV Fentanyl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center|
|Actual Study Start Date :||December 8, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Sublingual Sufentanil
Single dose of sublingual sufentanil for acute pain.
Drug: Sublingual Sufentanil
30 mcg of sublingual sufentanil
Active Comparator: IV Fentanyl
single dose of IV fentanyl for acute pain.
Drug: IV Fentanyl
50 mcg of IV fentanyl
- Time of Readiness to Discharge After Arrival in PACU [ 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.
- Opioid Use After Intervention Until Discharge [ Time Frame: 1 day ]All doses of opioid medications (commonly, fentanyl and oxycodone) 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177862
|Contact: Aaron Berg, MDfirstname.lastname@example.org|
|Contact: Jonah Pearsonemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Candace Nelson 612-626-2465 firstname.lastname@example.org|
|Principal Investigator:||Aaron M Berg, MD||University of Minnesota|