DSUVIA in Patients With SCD VOC Present in the ED

NCT05388188 | Unknown

• 1 other identifier: 20-0412
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Sickle Cell Disease; SCD; SCD VOC

Outcome Measures

Primary Outcomes (1)

• Time to Analgesia

  pain onset to inability to feel pain

  1 hour

Secondary Outcomes (2)

• Time at Hospital

  through study completion, an average of 1 week

• Measurement of morphine milligram equivalents (MME)

  3 hours

Study Arms (2)

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

sublingual sufentanil DRUG

Dsuvia in patients with SCD VOC as a bridging medication.

Also known as: Dsuvia Sublingual Product

Sickle Cell Disease Vaso-Occlusive (SCD VOC) crisis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Participant has a temperature of \> 100.4 F
• Participant has heart rate \> 120
• Participant has systolic blood pressure \< 90
• Clinical provider or investigator states that patient has "Acute Chest Syndrome"
• Participant unlikely to comply with protocol as determined by Investigator
• 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
• Persistent significant or severe infection, either acute or chronic
• No prior oral opioid use for SCD VOC pain control
• Participation in this study within the past 30 days.

Sponsors & Collaborators

• Jason Wilson: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Vaso-Occlusive Crises; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jason Wilson, MD

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Barnes, RN

CONTACT

813-660-6035; ashleynbarnes@tgh.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator/Medical Doctor

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: May 24, 2022
• Study Start: March 30, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

US (1)