DEEP: DSUVIA Early Evaluation of Pain Trial

• Sponsor: Frank Guyette (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05288348
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31.9
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Traumatic Injury	Drug: Sufentanil 30 MCG Sublingual Tablet; Drug: standard care pain treatment	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: DSUVIA Early Evaluation of PAIN (DEEP) Trial
• Actual Study Start Date: Aug 5, 2022
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Verbally administered Numeric Rating Scale (VNRS) [30 minutes after administration]

   Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

Secondary Outcome Measures

1. Verbally administered Numeric Rating Scale (VNRS) [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]

   Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

2. 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)]

3. 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)]

4. 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)]

5. Number of rescue narcotic doses [at 30 minutes following administration and during ED stay (up to 120 minutes)]

6. Time to reduction in VNRS pain score of 10 points [at 30 minutes following administration and every 30 minutes up to 120 minutes]

   determined by VNRS pain score (scale of 0-100, where 0 is having no pain)

7. Patient cognitive function as assessed by Six Item Screener (SIS) [at 30 minutes following administration]

8. Healthcare Professional Global Assessment (HPGA) of method of pain control [at 30 minutes following administration]

9. Acceptability of pain treatment to health care providers [at 30 minutes following administration or when feasible]

   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)

10. incidence of hypoxia needing supplemental oxygen [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

    SpO2 less than 90 percent

11. incidence of hypotension [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

    systolic blood pressure less than 90mmHg

12. advanced airway or bag mask ventilation [from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes)]

13. incidence of nausea [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

14. incidence of vomiting [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

15. incidence of headache [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

16. incidence of dizziness [from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Frank Guyette
• United States Department of Defense

Investigators

• Study Director: Jason Sperry, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Guyette, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05288348
• Other Study ID Numbers: STUDY21100180; W81XWH-16-D-0024
• First Posted: Mar 21, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Wounds and Injuries; Sufentanil

Study Results

No Results Posted as of Aug 25, 2022