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Completed

NCT Number: NCT05288348

DSUVIA Early Evaluation of Pain 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

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Key information

Conditions

Traumatic Injury Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil 30 MCG Sublingual Tablet

Drug

30 microgram sublingual tablet administered using sublingual applicator

standard care pain treatment

Drug

standard care pain treatment given in Emergency Department

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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

    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)

    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

  3. 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)

    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.

  4. Number of Participants Who Needed Rescue Narcotic Doses

    Time frame: 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.

  5. Patient Cognitive Function as Assessed by Six Item Screener (SIS)

    Time frame: 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.

  6. Healthcare Professional Global Assessment (HPGA) of Method of Pain Control

    Time frame: 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.

  7. 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)

    The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen

  8. Number of Participants With Hypotension

    Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

    systolic blood pressure less than 90mmHg

  9. Number of Participants With Nausea

    Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

  10. Number of Participants With Vomiting

    Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

  11. Number of Participants With Headache

    Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

  12. 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)

    Dizziness requiring treatment

  13. 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

    The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min

  14. 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

    Need for advanced airway or bag valve mask ventilation

  15. Richmond Agitation-Sedation Scale (RASS)

    Time frame: Assessed at 30 minutes after administration

    The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.

  16. Richmond Agitation-Sedation Scale (RASS) @ 60 Min

    Time frame: 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.

  17. Richmond Agitation-Sedation Scale (RASS) @ 90 Min

    Time frame: RASS @ 90 minutes

    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.

  18. Richmond Agitation-Sedation Scale (RASS) @ 120 Min

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Frank Guyette

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

DSUVIA Early Evaluation of PAIN (DEEP) Trial

Acronym: DEEP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2022
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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