Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177862
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Pain, Acute Anesthesia Drug: Sublingual Sufentanil Drug: IV Fentanyl Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Adverse Events [ Time Frame: 1 day ]
    Number of serious adverse events (grades 3, 4, and 5) experienced by each group

  3. Postoperative nausea and vomiting (PONV) [ Time Frame: 1 day ]
    Number of participants in each arm who are treated for nausea and/or vomiting.

  4. Supplemental Oxygen [ Time Frame: 1 day ]
    Number of participants in each arm who require supplemental oxygen therapy

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Aaron Berg, MD 612-624-9990 bergx831@umn.edu
Contact: Jonah Pearson 612-625-6659 pears731@umn.edu

Locations
Layout table for location information
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Candace Nelson    612-626-2465    nelso377@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Aaron M Berg, MD University of Minnesota

Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04177862    
Other Study ID Numbers: STUDY00007956
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics