DSUVIA Early Evaluation of Pain Trial

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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 moderate to severe pain

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frank Guyette
• Collaborator: United States Department of Defense
• Treatments: Sufentanil

Criteria

Inclusion Criteria:

1. Trauma activation (Level I, II or III)

2. Age 18-70 years inclusive

3. Need for pain treatment based upon NRS (0-100) clinical pain measurement ≥ 50

4. Estimated time in Emergency Department > 30 minutes following informed consent

Exclusion Criteria:

1. Advanced airway management prior to 1st dose administration

2. Known allergy to opioids

3. Known prisoner

4. Known pregnancy

5. ED pain medication contraindicated

6. Significant respiratory depression

7. Known or suspected gastrointestinal obstruction, including paralytic ileus