Phase 3
N=150
DSUVIA Early Evaluation of Pain Trial
Traumatic Injury
Bottom Line
View on ClinicalTrials.gov: NCT05288348 ↗Enrolled (actual)
150
Serious AEs
8.7%
Results posted
Apr 2025
Primary outcome: Primary: Verbally Administered Numeric Rating Scale (VNRS) — 68; 66 units on a scale — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sufentanil 30 MCG Sublingual Tablet (Drug); standard care pain treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Frank Guyette
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbally Administered Numeric Rating Scale (VNRS) |
68; 66; 59; 66; 53; 64 | 0.18 |
| SECONDARY Verbally Administered Numeric Rating Scale (VNRS) |
68; 66; 59; 66; 53; 64 | 0.18 |
| SECONDARY Patient Global Assessment (PGA) of Pain Control |
22; 12; 21; 14; 17; 24 | 0.005 sig |
| SECONDARY Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min |
6; 7; 14; 14; 22; 22 | 0.39 |
| SECONDARY Number of Participants Who Needed Rescue Narcotic Doses |
27; 29 | 0.64 |
| SECONDARY Patient Cognitive Function as Assessed by Six Item Screener (SIS) |
20; 22; 7; 8; 5; 4 | 0.61 |
| SECONDARY Healthcare Professional Global Assessment (HPGA) of Method of Pain Control |
14; 5; 19; 14; 23; 28 | 0.009 sig |
| SECONDARY Number of Participants With Hypoxia Needing Supplemental Oxygen |
4; 4 | 0.96 |
| SECONDARY Number of Participants With Hypotension |
1; 1 | — |
| SECONDARY Number of Participants With Nausea |
5; 3 | — |
| SECONDARY Number of Participants With Vomiting |
3; 0 | — |
| SECONDARY Number of Participants With Headache |
1; 2 | — |
| SECONDARY Number of Participants With Dizziness Requiring Treatment |
0; 1 | >0.99 |
| SECONDARY Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min |
28; 36; 41; 41; 42; 43 | 0.90 |
| SECONDARY Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management |
0; 0 | — |
| SECONDARY Richmond Agitation-Sedation Scale (RASS) |
0; 0; 0; 0; 1; 0 | 0.99 |
| SECONDARY Richmond Agitation-Sedation Scale (RASS) @ 60 Min |
0; 0; 0; 0; 1; 1 | 0.84 |
| SECONDARY Richmond Agitation-Sedation Scale (RASS) @ 90 Min |
0; 0; 0; 1; 0; 0 | 0.81 |
| SECONDARY Richmond Agitation-Sedation Scale (RASS) @ 120 Min |
0; 0; 0; 0; 0; 0 | 0.74 |
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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05288348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.