Traumatic InjuryPhase 3DEEPNCT05288348
DSUVIA Early Evaluation of Pain Trial
A Phase 3 study testing Sufentanil 30 MCG Sublingual Tablet in people with Traumatic Injury, run by Frank Guyette at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- Sufentanil 30 MCG Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 21 Jan 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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
- Conditions
- Traumatic Injury
- Being tested
- Sufentanil 30 MCG Sublingual Tablet, standard care pain treatment
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil 30 MCG Sublingual TabletDrug
30 microgram sublingual tablet administered using sublingual applicator
standard care pain treatmentDrug
standard care pain treatment given in Emergency Department
| Study group | Role | What they receive |
|---|---|---|
| DSUVIA (sufentanil) | Experimental | Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator Receives: Drug: Sufentanil 30 MCG Sublingual Tablet |
| Standard Care | Active comparator | Subjects will receive standard care pain management Receives: Drug: standard care pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes after administration
Secondary outcomes (18)
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Nausea
Measured: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Vomiting
Measured: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Headache
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: RASS @ 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start5 Aug 2022
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Guyette
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Frank Guyette, University of Pittsburgh
- Investigators
- Jason Sperry, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288348
- Sponsor's protocol ID
- STUDY21100180
- Other IDs
- W81XWH-16-D-0024
- Acronym
- DEEP
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2022
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Publications
Guyette FX, Chaudhary P, Vincent LE, Love ET, Brubaker DP, Neal MD, Brown JB, Rixe J, Barton DJ, Yates A, Wisniewski SR, Sperry JL. A Randomized Controlled Trial of Sublingual Sufentanil in Early Management of Pain in Trauma. Anesth Analg. 2025 Jul 1;141(1):172-180. doi: 10.1213/ANE.0000000000007384. Epub 2025 Feb 7.
PubMed 39919020
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DSUVIA Early Evaluation of PAIN (DEEP) Trial
- ClinicalTrials.gov ID
- NCT05288348
- Acronym / sponsor ID
- DEEP / STUDY21100180
- Conditions
- Traumatic Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Frank GuyetteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSUVIA (sufentanil) | Experimental | Drug: Sufentanil 30 MCG Sublingual TabletSubjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator |
| Standard Care | Active comparator | Drug: standard care pain treatmentSubjects will receive standard care pain management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Advanced airway management prior to 1st dose administration
- Known allergy to opioids
- Known prisoner
- Known pregnancy
- ED pain medication contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil 30 MCG Sublingual Tablet30 microgram sublingual tablet administered using sublingual applicator | Drug | DSUVIA (sufentanil) |
| standard care pain treatmentstandard care pain treatment given in Emergency Department | Drug | Standard Care |
Primary outcome
Verbally Administered Numeric Rating Scale (VNRS)
Time frame: 30 minutes after administration
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
18 secondary outcomes
Verbally Administered Numeric Rating Scale (VNRS)
Time frame: 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
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)
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min
Time frame: 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
Time frame: at 30 minutes following administration and during ED stay (up to 120 minutes)
Patient Cognitive Function as Assessed by Six Item Screener (SIS)
Time frame: at 30 minutes following administration
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control
Time frame: at 30 minutes following administration
Number of Participants With Hypoxia Needing Supplemental Oxygen
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Hypotension
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Nausea
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Vomiting
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Headache
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Dizziness Requiring Treatment
Time frame: 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
Time frame: 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
Time frame: From drug administration up to 120 min following administration
Richmond Agitation-Sedation Scale (RASS)
Time frame: Assessed at 30 minutes after administration
Richmond Agitation-Sedation Scale (RASS) @ 60 Min
Time frame: RASS @ 60 min
Richmond Agitation-Sedation Scale (RASS) @ 90 Min
Time frame: RASS @ 90 minutes
Richmond Agitation-Sedation Scale (RASS) @ 120 Min
Time frame: RASS @ 120 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39919020Guyette FX, Chaudhary P, Vincent LE, Love ET, Brubaker DP, Neal MD, Brown JB, Rixe J, Barton DJ, Yates A, Wisniewski SR, Sperry JL. A Randomized Controlled Trial of Sublingual Sufentanil in Early Management of Pain in Trauma. Anesth Analg. 2025 Jul 1;141(1):172-180. doi: 10.1213/ANE.0000000000007384. Epub 2025 Feb 7.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Sperry, MD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sufentanil 30 MCG Sublingual Tablet in people with Traumatic Injury, run by Frank Guyette at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbally Administered Numeric Rating Scale (VNRS) (time frame: 30 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.