Trial · NCT05288348
DSUVIA Early Evaluation of Pain Trial
NCT05288348, Phase 3, Completed, Frank Guyette; results first posted 2025-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DSUVIA Early Evaluation of Pain Trial. Trials, record NCT05288348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05288348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DSUVIA Early Evaluation of Pain Trial
- NCT number
- NCT05288348
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Frank Guyette
- Conditions
- Traumatic Injury
- Interventions
- Sufentanil 30 MCG Sublingual Tablet, standard care pain treatment
- First posted
- 2022-03-21
- Last updated
- 2025-04-30
- Results first posted
- 2025-04-30
- Limitations and caveats
Our study is a first of its kind comparing sublingual sufentanil to standard care in trauma patients. The intervention could not be blinded which imparts bias. This study was conducted at two level 1 trauma centers in the city of Pittsburgh and while the population was typical of our region, it may not be broadly generalizable. We did not dictate the choice or dose of analgesic in the standard arm. There was missingness in the data and no primary outcome was recorded in 20 subjects.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Verbally Administered Numeric Rating Scale (VNRS) | 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 | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) |
| 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) | 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 |
| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 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. |
| Secondary | Number of Participants Who Needed Rescue Narcotic Doses | at 30 minutes following administration and during ED stay (up to 120 minutes) | Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control. |
| Secondary | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | at 30 minutes following administration | 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. |
| Secondary | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | at 30 minutes following administration | 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. |
| Secondary | Number of Participants With Hypoxia Needing Supplemental Oxygen | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen |
| Secondary | Number of Participants With Hypotension | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | systolic blood pressure less than 90mmHg |
| Secondary | Number of Participants With Nausea | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Verbally Administered Numeric Rating Scale (VNRS) | 30 minutes after administration | units on a scale | MEAN | |
| SECONDARY | Verbally Administered Numeric Rating Scale (VNRS) | 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 | The number of patients analyzed at subsequent time points decreases as patients received rescue medications or left the Emergency Department (for admission, operative intervention, or discharge) prior to the 2 hr follow up period. | units on a scale | MEAN |
| 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) | Patient Global Assessment of Pain Control at 30 min | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | units on a scale | MEAN | |
| SECONDARY | Number of Participants Who Needed Rescue Narcotic Doses | at 30 minutes following administration and during ED stay (up to 120 minutes) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | at 30 minutes following administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | at 30 minutes following administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Hypoxia Needing Supplemental Oxygen | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Hypotension | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Nausea | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Verbally Administered Numeric Rating Scale (VNRS) | DSUVIA (Sufentanil) | 68 | Standard Deviation 27 | units on a scale | |
| Verbally Administered Numeric Rating Scale (VNRS) | Standard Care | 66 | Standard Deviation 23 | units on a scale | |
| Verbally Administered Numeric Rating Scale (VNRS) | DSUVIA (Sufentanil) | 30 minutes | 68 | Standard Deviation 27 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | Standard Care | 30 minutes | 66 | Standard Deviation 23 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | DSUVIA (Sufentanil) | 60 minutes | 59 | Standard Deviation 29 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | Standard Care | 60 minutes | 66 | Standard Deviation 27 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | DSUVIA (Sufentanil) | 90 minutes | 53 | Standard Deviation 29 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | Standard Care | 90 minutes | 64 | Standard Deviation 27 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | DSUVIA (Sufentanil) | 120 minutes | 53 | Standard Deviation 30 | units on a scale |
| Verbally Administered Numeric Rating Scale (VNRS) | Standard Care | 120 minutes | 62 | Standard Deviation 28 | units on a scale |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DSUVIA (Sufentanil) | 76 | |
| Overall Study | STARTED | Standard Care | 74 | |
| Overall Study | COMPLETED | DSUVIA (Sufentanil) | 76 | |
| Overall Study | COMPLETED | Standard Care | 74 | |
| Overall Study | NOT COMPLETED | DSUVIA (Sufentanil) | 0 | |
| Overall Study | NOT COMPLETED | Standard Care | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | DSUVIA (Sufentanil) | 0 | 76 | 0 |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Standard Care | 0 | 74 | 0 |
| other | Hypotension | General disorders | DSUVIA (Sufentanil) | 0 | 76 | 0 |
| other | Hypotension | General disorders | Standard Care | 0 | 74 | 0 |
| other | Nausea | Gastrointestinal disorders | DSUVIA (Sufentanil) | 4 | 76 | 4 |
| other | Nausea | Gastrointestinal disorders | Standard Care | 2 | 74 | 2 |
| other | Vomiting | Gastrointestinal disorders | DSUVIA (Sufentanil) | 2 | 76 | 2 |
| other | Vomiting | Gastrointestinal disorders | Standard Care | 0 | 74 | 0 |
| other | Headache | Nervous system disorders | DSUVIA (Sufentanil) | 1 | 76 | 1 |
| other | Headache | Nervous system disorders | Standard Care | 2 | 74 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DSUVIA (Sufentanil) | 0 | 76 |
| Total, all-cause mortality | Standard Care | 0 | 74 |
| Total, other adverse events | DSUVIA (Sufentanil) | 5 | 76 |
| Total, other adverse events | Standard Care | 4 | 74 |
| Total, serious adverse events | DSUVIA (Sufentanil) | 7 | 76 |
| Total, serious adverse events | Standard Care | 6 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39919020 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Vomiting | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Nausea | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Hypoxia Needing Supplemental Oxygen | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants Who Needed Rescue Narcotic Doses | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Dizziness Requiring Treatment | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Headache | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: Number of Participants With Hypotension | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: deaths from any cause | Trial comparisons |
| DSUVIA (Sufentanil) vs Standard Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05288348
GET https://conductscience.org/api/trials/v1/NCT05288348/results?page=2