DSUVIA Early Evaluation of Pain Trial

NCT05288348 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: STUDY21100180W81XWH-16-D-0024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 moderate to severe pain

Conditions

Traumatic Injury

Outcome Measures

Primary Outcomes (1)

• Verbally Administered Numeric Rating Scale (VNRS)

  Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

  30 minutes after administration

Secondary Outcomes (18)

• Verbally Administered Numeric Rating Scale (VNRS)

  Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first

• Patient Global Assessment (PGA) of Pain Control

  every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)

• Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min

  every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)

• Number of Participants Who Needed Rescue Narcotic Doses

  at 30 minutes following administration and during ED stay (up to 120 minutes)

• Patient Cognitive Function as Assessed by Six Item Screener (SIS)

  at 30 minutes following administration

Study Arms (2)

DSUVIA (sufentanil)

EXPERIMENTAL

Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator

Drug: Sufentanil 30 MCG Sublingual Tablet

Standard Care

ACTIVE COMPARATOR

Subjects will receive standard care pain management

Drug: standard care pain treatment

Interventions

Sufentanil 30 MCG Sublingual Tablet DRUG

30 microgram sublingual tablet administered using sublingual applicator

DSUVIA (sufentanil)

standard care pain treatment DRUG

standard care pain treatment given in Emergency Department

Standard Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Guyette: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 39919020 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Sufentanil; Administration, Sublingual

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Our study is a first of its kind comparing sublingual sufentanil to standard care in trauma patients. The intervention could not be blinded which imparts bias. This study was conducted at two level 1 trauma centers in the city of Pittsburgh and while the population was typical of our region, it may not be broadly generalizable. We did not dictate the choice or dose of analgesic in the standard arm. There was missingness in the data and no primary outcome was recorded in 20 subjects.

Results Point of Contact

• Title: Francis X Guyette
• Organization: University of Pittsburgh

guyettef@upmc.edu

412 651 1077

Study Officials

• Jason Sperry, MD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 21, 2022
• Study Start: August 5, 2022
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript
• Access Criteria: Requests for data will be submitted in writing and reviewed by the principal Investigator

Locations

US (1)