Status:
COMPLETED
DSUVIA Early Evaluation of Pain Trial
Lead Sponsor:
Frank Guyette
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with mode...
Eligibility Criteria
Inclusion
- Trauma activation (Level I, II or III)
- Age 18-70 years inclusive
- Need for pain treatment based upon NRS (0-100) clinical pain measurement ≥ 50
- Estimated time in Emergency Department \> 30 minutes following informed consent
Exclusion
- Advanced airway management prior to 1st dose administration
- Known allergy to opioids
- Known prisoner
- Known pregnancy
- ED pain medication contraindicated
- Significant respiratory depression
- Known or suspected gastrointestinal obstruction, including paralytic ileus
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05288348
Start Date
August 5 2022
End Date
January 21 2024
Last Update
April 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213