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Status unknownNCT05388188Updated May 24, 2022

DSUVIA in Patients With SCD VOC Present in the ED

An observational study in Sickle-Cell Disease With Crisis, sponsored by Jason Wilson. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Jason Wilson · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

This is an observational study to improve the treatment of patients with Sickle Cell Disease Vaso-Occlusive Crisis by administering pain medications more quickly after the patient arrives in the emergency department. Specifically, we are using a sublingual opioid called sufentanil [Dsuvia] that has already been approved by the Food and Drug Administration (FDA) for the treatment of acute pain. It is being studied as part of this research study to find out if we can relieve the patients pain more quickly and decrease the amount of time the patient needs to spend in the hospital by avoiding a hospital admission after the patients emergency department encounter if the patients pain is adequately controlled.

Read the detailed description

Patients with SCD VOC may present to the ED after oral home medications fail to relieve acute pain. Patients with SCD VOC may require parenteral analgesia for pain relief but, upon arrival to the ED these patients often undergo long wait times until receiving first parenteral medication dose. Oral opioid pain medications are not adequate as most adult patients with SCD and history of SCD VOC have already tried utilizing oral opioids out of the hospital. Intravenous access is challenging in this population with venous scarring or central ports that require sterile access. The need to establish IV access and to, eventually, provide parenteral opioids results in long delays in the time to first dose of drug (time to analgesia) in patients with SCD VOC that present to the ED. Delays in analgesia increase the likelihood of hospital admission in patients with SCD VOC that present to the ED. Patients with SCD VOC that are admitted to the hospital often have a long LOS. A bridge medication or intervention is needed for patients with SCD VOC upon entry into the ED that provides adequate and timely analgesia. In 2020, our ED began utilizing Dsuvia in patients with SCD VOC as a bridging medication. Data has not been collected to specifically examine the impact of Dsuvia use on patient throughput metrics and disposition.

Use of Dsuvia in ED patients with SCD VOC will decrease door to first analgesic time (time to analgesia). Decrease of door to first analgesic time will decrease the overall admission rate for patients with SCD VOC without decreasing patient or staff satisfaction. Use of STL Dsuvia will not lead to an increase in adverse patient safety events. Patients that receive Dsuvia early in the ED encounter may also require a lower overall amount of opioids, represented by morphine milligram equivalents (MME) than patients in a historical control group that did not receive Dsuvia. In addition, this study extends evidence for efficacy of Dsuvia in patients with acute pain but a history of opioid tolerance (unlike prior studies with Dsuvia that excluded patients with opioid tolerance). Since 2020, our ED standard of care for patients with SCD VOC is to utilize Dsuvia as early as possible in the ED course.

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Conditions studied

  • Sickle-Cell Disease With Crisis

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Keywords

  • Sickle Cell Disease
  • SCD
  • SCD VOC
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In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

This is the only study on the registry with Jason Wilson as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with known sickle cell disease that present to the ED with a SCD VOC

Inclusion criteria

  1. Age >= 18
  2. Known history/self-reported history of Sickle Cell Disease
  3. Participant has self-described sickle cell related pain
  4. Patient has attempted to utilize oral opioid pain medications in the last 24 hours

Exclusion criteria

Exclusion Criteria:

  1. Unable to provide informed consent to participate in the study, such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
  2. Participant has a temperature of > 100.4 F
  3. Participant has heart rate > 120
  4. Participant has systolic blood pressure \< 90
  5. Clinical provider or investigator states that patient has "Acute Chest Syndrome"
  6. Participant unlikely to comply with protocol as determined by Investigator
  7. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
  8. Persistent significant or severe infection, either acute or chronic
  9. No prior oral opioid use for SCD VOC pain control
  10. Participation in this study within the past 30 days.
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sickle Cell Disease Vaso-Occlusive (SCD VOC) crisis

    Adult patients with known sickle cell disease present in the ED with a SCD VOC and ED provider has ordered as part of the patient's standard of care, sublingual opioid called sufentanil \[Dsuvia\] (a strong pain medicine that dissolves under your tongue) for the patient.

    Drug: sublingual sufentanil

  • Historical Sample

    collection of retrospective data of SCD VOC patients.

Interventions

  • Drugsublingual sufentanil

    Dsuvia in patients with SCD VOC as a bridging medication.

    Also known as: Dsuvia Sublingual Product

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What researchers measure

Primary outcomes

  1. Time to Analgesia

    pain onset to inability to feel pain

    Time frame: 1 hour

Secondary outcomes

  1. Time at Hospital

    Length of time in the ED and/or length of stay in the hospital

    Time frame: through study completion, an average of 1 week

  2. Measurement of morphine milligram equivalents (MME)

    Total MME in patients receiving Dsuvia during ED encounter

    Time frame: 3 hours

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Study locations

1 of 1 sites recruiting
  • Tampa General Hospital
    Tampa, Florida 33606, United States
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05388188
Lead sponsor
Jason Wilson
Responsible party
Jason Wilson (Principal Investigator/Medical Doctor, Tampa General Hospital) — Sponsor-investigator
First posted
May 24, 2022
Start date
Mar 30, 2022
Primary completion
Apr 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
May 24, 2022

Study contacts

Ashley Barnes, RN
Contact
ashleynbarnes@tgh.org
813-660-6035
Jason Wilson, MD
principal investigator · Tampa General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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