Clinical trial NCT05288348: DSUVIA Early Evaluation of Pain Trial
Official title: DSUVIA Early Evaluation of PAIN (DEEP) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Injury
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Verbally Administered Numeric Rating Scale (VNRS)
timeFrame: 30 minutes after administration
Secondary outcomes:
measure: Verbally Administered Numeric Rating Scale (VNRS)
timeFrame: Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first
measure: Patient Global Assessment (PGA) of Pain Control
timeFrame: every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
measure: Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min
timeFrame: every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
measure: Number of Participants Who Needed Rescue Narcotic Doses
timeFrame: at 30 minutes following administration and during ED stay (up to 120 minutes)
measure: Patient Cognitive Function as Assessed by Six Item Screener (SIS)
timeFrame: at 30 minutes following administration
measure: Healthcare Professional Global Assessment (HPGA) of Method of Pain Control
timeFrame: at 30 minutes following administration
measure: Number of Participants With Hypoxia Needing Supplemental Oxygen
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants With Hypotension
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants With Nausea
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants With Vomiting
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants With Headache
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants With Dizziness Requiring Treatment
timeFrame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
measure: Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min
timeFrame: Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals
measure: Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management
timeFrame: From drug administration up to 120 min following administration
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: Assessed at 30 minutes after administration
measure: Richmond Agitation-Sedation Scale (RASS) @ 60 Min
timeFrame: RASS @ 60 min
measure: Richmond Agitation-Sedation Scale (RASS) @ 90 Min
timeFrame: RASS @ 90 minutes
measure: Richmond Agitation-Sedation Scale (RASS) @ 120 Min
timeFrame: RASS @ 120 min
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jason Sperry, MD
role: STUDY_DIRECTOR
References: