CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Sufentanil 30 MCG Sublingual Tablet +1 moredrug
Likely dose
Sufentanil 30 microgram sublingual tablet administered using sublingual applicatorAI-extracted
Key inclusion· 4
  • ✓Trauma activation (Level I, II, or III)
  • ✓Age 18–70 years
  • ✓Clinical pain score (NRS) ≥50 at baseline
  • ✓Expected ED stay >30 minutes after consent
Key exclusion· 6
  • ✕Advanced airway management prior to first dose
  • ✕Known allergy to opioids
  • ✕Prisoner status
  • ✕Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05288348
NCT05288348Phase 3Completed
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DSUVIA Early Evaluation of PAIN (DEEP) Trial

Frank Guyette·interventional·Posted Mar 21, 2022·Updated Apr 30, 2025

In Brief

A Phase 3 clinical trial evaluating Sufentanil 30 MCG Sublingual Tablet and standard care pain treatment for Traumatic Injury. Completed, enrolled 150 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Injury
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 21, 2022
Enrollment StartAug 5, 2022
Primary CompletionJan 21, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.3 years ago

Interventions

Sufentanil 30 MCG Sublingual Tabletdrug

30 microgram sublingual tablet administered using sublingual applicator

standard care pain treatmentdrug

standard care pain treatment given in Emergency Department