DSUVIA Early Evaluation of Pain Trial

Traumatic Injury Clinical Trial

— DEEP  

Official title:

DSUVIA Early Evaluation of PAIN (DEEP) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288348
• Other study ID #: STUDY21100180
• Secondary ID: W81XWH-16-D-0024
• Status: Completed
• Phase: Phase 3
• Start date: August 5, 2022
• Est. completion date: January 21, 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 21, 2024
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Sufentanil 30 MCG Sublingual Tablet
30 microgram sublingual tablet administered using sublingual applicator
• standard care pain treatment
standard care pain treatment given in Emergency Department

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Frank Guyette	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of rescue narcotic doses		at 30 minutes following administration and during ED stay (up to 120 minutes)
Secondary	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
Secondary	Patient cognitive function as assessed by Six Item Screener (SIS)		at 30 minutes following administration
Secondary	Healthcare Professional Global Assessment (HPGA) of method of pain control		at 30 minutes following administration
Secondary	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
Secondary	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)
Secondary	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)
Secondary	advanced airway or bag mask ventilation		from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes)
Secondary	incidence of nausea		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary	incidence of vomiting		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary	incidence of headache		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary	incidence of dizziness		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)