DSUVIA Early Evaluation of Pain Trial (DEEP)

Frank Guyette

Status and phase: Completed; Phase 3

Conditions: Traumatic Injury

Treatments: Drug: standard care pain treatment; Drug: Sufentanil 30 MCG Sublingual Tablet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05288348

W81XWH-16-D-0024 (Other Grant/Funding Number)

STUDY21100180

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

DSUVIA (sufentanil)

Experimental group

Description:

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

Treatment:

Drug: Sufentanil 30 MCG Sublingual Tablet

Standard Care

Active Comparator group

Description:

Subjects will receive standard care pain management

Treatment:

Drug: standard care pain treatment