DSUVIA Early Evaluation of Pain Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2024-01-21

Brief Summary

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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

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Detailed Description

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Conditions

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Traumatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DSUVIA (sufentanil)

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

Group Type EXPERIMENTAL

Sufentanil 30 MCG Sublingual Tablet

Intervention Type DRUG

30 microgram sublingual tablet administered using sublingual applicator

Standard Care

Subjects will receive standard care pain management

Group Type ACTIVE_COMPARATOR

standard care pain treatment

Intervention Type DRUG

standard care pain treatment given in Emergency Department

Interventions

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Sufentanil 30 MCG Sublingual Tablet

30 microgram sublingual tablet administered using sublingual applicator

Intervention Type DRUG

standard care pain treatment

standard care pain treatment given in Emergency Department

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No