DSUVIA Early Evaluation of Pain Trial (DEEP)
Primary Purpose
Traumatic Injury
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sufentanil 30 MCG Sublingual Tablet
standard care pain treatment
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Injury
Eligibility Criteria
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
Sites / Locations
- University of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DSUVIA (sufentanil)
Standard Care
Arm Description
Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator
Subjects will receive standard care pain management
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Patient Global Assessment (PGA) of Pain Control
Richmond Agitation-Sedation Scale (RASS)
time-weighted Summed Pain Intensity Difference (SPID)
Number of rescue narcotic doses
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)
Patient cognitive function as assessed by Six Item Screener (SIS)
Healthcare Professional Global Assessment (HPGA) of method of pain control
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)
incidence of hypoxia needing supplemental oxygen
SpO2 less than 90 percent
incidence of hypotension
systolic blood pressure less than 90mmHg
advanced airway or bag mask ventilation
incidence of nausea
incidence of vomiting
incidence of headache
incidence of dizziness
Full Information
NCT ID
NCT05288348
First Posted
February 22, 2022
Last Updated
August 8, 2023
Sponsor
Frank Guyette
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05288348
Brief Title
DSUVIA Early Evaluation of Pain Trial
Acronym
DEEP
Official Title
DSUVIA Early Evaluation of PAIN (DEEP) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank Guyette
Collaborators
United States Department of Defense
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DSUVIA (sufentanil)
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Subjects will receive standard care pain management
Intervention Type
Drug
Intervention Name(s)
Sufentanil 30 MCG Sublingual Tablet
Intervention Description
30 microgram sublingual tablet administered using sublingual applicator
Intervention Type
Drug
Intervention Name(s)
standard care pain treatment
Intervention Description
standard care pain treatment given in Emergency Department
Primary Outcome Measure Information:
Title
Verbally administered Numeric Rating Scale (VNRS)
Description
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time Frame
30 minutes after administration
Secondary Outcome Measure Information:
Title
Verbally administered Numeric Rating Scale (VNRS)
Description
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time Frame
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
Title
Patient Global Assessment (PGA) of Pain Control
Time Frame
every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Title
Richmond Agitation-Sedation Scale (RASS)
Time Frame
every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Title
time-weighted Summed Pain Intensity Difference (SPID)
Time Frame
every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Title
Number of rescue narcotic doses
Time Frame
at 30 minutes following administration and during ED stay (up to 120 minutes)
Title
Time to reduction in VNRS pain score of 10 points
Description
determined by VNRS pain score (scale of 0-100, where 0 is having no pain)
Time Frame
at 30 minutes following administration and every 30 minutes up to 120 minutes
Title
Patient cognitive function as assessed by Six Item Screener (SIS)
Time Frame
at 30 minutes following administration
Title
Healthcare Professional Global Assessment (HPGA) of method of pain control
Time Frame
at 30 minutes following administration
Title
Acceptability of pain treatment to health care providers
Description
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)
Time Frame
at 30 minutes following administration or when feasible
Title
incidence of hypoxia needing supplemental oxygen
Description
SpO2 less than 90 percent
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Title
incidence of hypotension
Description
systolic blood pressure less than 90mmHg
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Title
advanced airway or bag mask ventilation
Time Frame
from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes)
Title
incidence of nausea
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Title
incidence of vomiting
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Title
incidence of headache
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Title
incidence of dizziness
Time Frame
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Sperry, MD
Phone
412-802-8270
Email
sperryjl@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD, MPH
Phone
412-647-3065
Email
sperryjl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Francis Guyette, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
DSUVIA Early Evaluation of Pain Trial
We'll reach out to this number within 24 hrs