DSUVIA Early Evaluation of Pain Trial

Study Overview
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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

Official Title
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DSUVIA Early Evaluation of PAIN (DEEP) Trial

Conditions
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Traumatic Injury

Intervention / Treatment
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* Drug: Sufentanil 30 MCG Sublingual Tablet
* Drug: standard care pain treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma activation (Level I, II or III) Age 18-70 years inclusive Need for pain treatment based upon NRS (0-100) clinical pain measurement ≥ 50 Estimated time in Emergency Department > 30 minutes following informed consent Exclusion Criteria: Advanced airway management prior to 1st dose administration Known allergy to opioids Known prisoner Known pregnancy ED pain medication contraindicated Significant respiratory depression Known or suspected gastrointestinal obstruction, including paralytic ileus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSUVIA (sufentanil)<br>Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator | Drug: Sufentanil 30 MCG Sublingual Tablet<br>* 30 microgram sublingual tablet administered using sublingual applicator<br>|
| Active Comparator: Standard Care<br>Subjects will receive standard care pain management | Drug: standard care pain treatment<br>* standard care pain treatment given in Emergency Department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbally administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | 30 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbally administered Numeric Rating Scale (VNRS) | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first | 
| Patient Global Assessment (PGA) of Pain Control |  | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 
| Richmond Agitation-Sedation Scale (RASS) |  | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 
| time-weighted Summed Pain Intensity Difference (SPID) |  | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 
| Number of rescue narcotic doses |  | at 30 minutes following administration and during ED stay (up to 120 minutes) | 
| Time to reduction in VNRS pain score of 10 points | determined by VNRS pain score (scale of 0-100, where 0 is having no pain) | at 30 minutes following administration and every 30 minutes up to 120 minutes | 
| Patient cognitive function as assessed by Six Item Screener (SIS) |  | at 30 minutes following administration | 
| Healthcare Professional Global Assessment (HPGA) of method of pain control |  | at 30 minutes following administration | 
| Acceptability of pain treatment to health care providers | 5-point scale score of providers assessment of individual patient's pain management process, ease, and acceptability relative to past experience (scale of minus 2 to plus 2, where minus 2 is very dissatisfied and plus 2 is very satisfied) | at 30 minutes following administration or when feasible | 
| incidence of hypoxia needing supplemental oxygen | SpO2 less than 90 percent | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | 
| incidence of hypotension | systolic blood pressure less than 90mmHg | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | 
| advanced airway or bag mask ventilation |  | from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes) | 
| incidence of nausea |  | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | 
| incidence of vomiting |  | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | 
| incidence of headache |  | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | 
| incidence of dizziness |  | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |