DSUVIA Early Evaluation of Pain Trial (DEEP)

DSUVIA Early Evaluation of PAIN (DEEP) Trial

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

Study Overview

• Status: Completed
• Conditions: Traumatic Injury
• Intervention / Treatment: Drug: Sufentanil 30 MCG Sublingual Tablet; Drug: standard care pain treatment

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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 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
Patient Global Assessment (PGA) of Pain Control	An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication	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) @ 30, 60, 90, 120 Min	time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration.	every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Number of Participants Who Needed Rescue Narcotic Doses	Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control.	at 30 minutes following administration and during ED stay (up to 120 minutes)
Patient Cognitive Function as Assessed by Six Item Screener (SIS)	The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.	at 30 minutes following administration
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control	Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent.	at 30 minutes following administration
Number of Participants With Hypoxia Needing Supplemental Oxygen	The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen	from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Hypotension	systolic blood pressure less than 90mmHg	from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Nausea		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Vomiting		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Headache		from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Dizziness Requiring Treatment	Dizziness requiring treatment	from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min	The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min	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
Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management	Need for advanced airway or bag valve mask ventilation	From drug administration up to 120 min following administration
Richmond Agitation-Sedation Scale (RASS)	The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.	Assessed at 30 minutes after administration
Richmond Agitation-Sedation Scale (RASS) @ 60 Min	The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.	RASS @ 60 min
Richmond Agitation-Sedation Scale (RASS) @ 90 Min	The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.	RASS @ 90 minutes
Richmond Agitation-Sedation Scale (RASS) @ 120 Min	The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.	RASS @ 120 min

Collaborators and Investigators

• Sponsor: Frank Guyette
• Collaborators: United States Department of Defense
• Investigators: Study Director: Jason Sperry, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): January 21, 2024
• Study Completion (Actual): January 21, 2024

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Sufentanil
• Other Study ID Numbers: STUDY21100180; W81XWH-16-D-0024 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
• IPD Sharing Time Frame: Data will become available after publication of the primary manuscript
• IPD Sharing Access Criteria: Requests for data will be submitted in writing and reviewed by the principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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