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

Must not have

Advanced airway management prior to 1st dose administration

ED pain medication contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 minutes following administration and every 30 minutes up to 120 minutes

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had advanced airway management before my first dose.

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Pain medication through IV or injection is not safe for me.

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I have severe breathing problems.

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I have or might have a blockage in my intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 minutes following administration and every 30 minutes up to 120 minutes

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.