DSUVIA Early Evaluation of Pain Trial

Phase 3 Completed 150 enrolled Frank Guyette United States Department of Defense · collab

RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start: 2022-08-05
Primary completion: 2024-01-21
Completion: 2024-01-21

Outcome

Missed primary endpoint

registry analysis (superiority test); DSUVIA (Sufentanil) vs Standard Care; p = 0.56; Mean Difference (Final Values) 2.57 (95% CI -6.19 to 11.33) NCT05288348 ↗

paper CONCLUSIONS: In this cohort of trauma patients with moderate to severe pain, the VNRS at 30 minutes after administration of analgesics did not differ between sublingual sufentanil and standard care. PMID 39919020 ↗

Publications

Guyette FX, Chaudhary P, Vincent LE, Love ET, Brubaker DP, Neal MD, Brown JB, Rixe J, Barton DJ, Yates A, Wisniewski SR, Sperry JL. A Randomized Controlled Trial of Sublingual Sufentanil in Early Management of Pain in Trauma. Anesth Analg. 2025 Jul 1;141(1):172-180. doi: 10.1213/ANE.0000000000007384. Epub 2025 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	30 ug	Other

Indications

No indication recorded.