Sufentanil for Pain Relief
(DEEP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Frank Guyette

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Jason Sperry, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults aged 18-70 who have moderate to severe pain from injuries and need treatment in the Emergency Department. They must score ≥50 on a pain scale and be expected to stay in the ED for over 30 minutes after consenting. It's not open to prisoners, pregnant individuals, those with opioid allergies, respiratory depression, or gastrointestinal blockages.

Inclusion Criteria

I was involved in a serious incident requiring emergency response.

I am between 18 and 70 years old.

My pain level is 50 or higher on a 0-100 scale.

See 1 more

Exclusion Criteria

I have or might have a blockage in my intestines.

I have severe breathing problems.

Known prisoner

See 4 more

Treatment Details

Interventions

Standard Care Pain Treatment (Drug)
Sufentanil (Opioid Analgesic)

Trial OverviewThe study compares DSUVIA (sufentanil), a strong painkiller given under the tongue, against standard care treatments for managing pain in trauma patients. Participants are randomly assigned to receive either DSUVIA or standard care to see which is more effective at reducing their pain.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: DSUVIA (sufentanil)Experimental Treatment1 Intervention

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

Group II: Standard CareActive Control1 Intervention

Subjects will receive standard care pain management