Recruiting

DSUVIA

Sponsor:

Jason Wilson

Code:

NCT05388188

Conditions

Sickle-Cell Disease With Crisis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sublingual sufentanil

Study Details

Brief 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.

Conditions

Sickle-Cell Disease With Crisis

Study ID

NCT05388188

Start date

Mar 30, 2022

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Historical Sample

collection of retrospective data of SCD VOC patients.

Interventions

sublingual sufentanil

Dsuvia in patients with SCD VOC as a bridging medication.

Primary outcome measure

  • Time to Analgesia [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Ashley Barnes, RN

813-660-6035ashleynbarnes@tgh.org

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Ashley Barnes, RN

813-660-6035ashleybarnes@tgh.org

More Information

Sponsor

Jason Wilson

Last update posted

May 24, 2022

Last verified

May, 2022

Keywords

  • Sickle Cell Disease
  • SCD
  • SCD VOC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jason Wilson on 2022-05-24.