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Opioid Analgesic

Sufentanil for Pain Relief (DEEP Trial)

Phase 3
Waitlist Available
Research Sponsored by Frank Guyette
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Trauma activation (Level I, II or III)
Age 18-70 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 minutes following administration and every 30 minutes up to 120 minutes
Awards & highlights

DEEP Trial Summary

This trial looks at whether giving sufentanil to patients in the emergency department for pain relief works better than standard care.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Sufentanil can cause typical opioid side effects like nausea, vomiting, dizziness, constipation, sleepiness and potentially serious breathing problems. The severity of side effects varies among individuals.

DEEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was involved in a serious incident requiring emergency response.
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I am between 18 and 70 years old.
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My pain level is 50 or higher on a 0-100 scale.
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I expect to stay in the ER for more than 30 minutes after giving consent.

DEEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 minutes following administration and every 30 minutes up to 120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 minutes following administration and every 30 minutes up to 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Pain
Healthcare Professional Global Assessment (HPGA) of method of pain control
Number of rescue narcotic doses
+13 more

DEEP Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil 30 MCG Sublingual Tablet
2022
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Frank GuyetteLead Sponsor
United States Department of DefenseFED
861 Previous Clinical Trials
227,044 Total Patients Enrolled
Jason Sperry, MDStudy DirectorUniversity of Pittsburgh
3 Previous Clinical Trials
2,130 Total Patients Enrolled

Media Library

Sufentanil (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05288348 — Phase 3
Traumatic Injury Research Study Groups: Standard Care, DSUVIA (sufentanil)
Traumatic Injury Clinical Trial 2023: Sufentanil Highlights & Side Effects. Trial Name: NCT05288348 — Phase 3
Sufentanil (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288348 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more slots available for volunteers in this experiment?

"Yes, as of 8/23/2022 this study is looking for patients to enroll. The first posting was on 8/5/2022."

Answered by AI

What is the uppermost limit to how many people can be a part of this test simultaneously?

"That is correct. The information provided on clinicaltrials.gov does show that the study is still recruiting patients. 150 participants are needed in total, and recruitment will take place at a single site."

Answered by AI

Are people of age for this trial being accepted?

"This study includes all patients that are aged 18-70, as specified in the enrollment requirements."

Answered by AI

What are the risks associated with taking Sufentanil 30 MCG Sublingual Tablet?

"Given that this is a Phase 3 trial with some data supporting efficacy as well as multiple rounds of data affirming safety, our team at Power has given Sufentanil 30 MCG Sublingual Tablet a score of 3 for safety."

Answered by AI

Which type of patient would be the best fit for this trial?

"This study is seeking to enroll 150 individuals who have recently experienced a traumatic injury and are aged between 18-70. The most important requirements for participants are: that they must be trauma patients (Level I, II or III), in need of pain treatment as indicated by an NRS score of ≥ 50, and have been in the Emergency Department for more than 30 minutes following informed consent."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
DSUVIA Early Evaluation of Pain Trial
Frank Guyette 2022. "DSUVIA Early Evaluation of Pain Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288348.
~56 spots leftby Apr 2025
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