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Enhanced Emergency Care for Sickle Cell Crisis (SCIENCE Trial)

N/A
Recruiting
Led By David Brousseau, MD, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of sickle cell disease
Receipt of at least one opioid
Must not have
Priapism
Sickle cell trait
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a maximum of about 6 hours as all opioids received during the ed stay will be captured
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a care pathway to see if it increases guideline adherent care for children in the emergency department who have sickle cell disease and are in acute pain.

Who is the study for?
This trial is for children with Sickle Cell Disease (SCD) who visit the emergency department due to a pain crisis and have received at least one opioid. It's not for those with fever over 38.5°C, priapism, sickle cell trait, or acute chest syndrome during their ED visit.
What is being tested?
The study tests a care pathway designed to ensure that children with SCD receive timely and guideline-adherent pain management in the emergency department. The goal is to reduce hospitalizations and improve quality of life by adhering to established pain management guidelines.
What are the potential side effects?
Since this trial focuses on implementing a care pathway rather than testing new medications, there are no direct side effects from interventions being studied. However, general risks associated with opioid use may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with sickle cell disease.
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I have taken opioids at least once.
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I visited the ER for a pain crisis that didn't have complications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced prolonged erections.
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I have sickle cell trait.
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I have had acute chest syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a maximum of about 6 hours as all opioids received during the ed stay will be captured
This trial's timeline: 3 weeks for screening, Varies for treatment, and a maximum of about 6 hours as all opioids received during the ed stay will be captured for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Timeliness of receipt of opioids
Secondary study objectives
Median time to opioids
Percent of children hospitalized

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Post-interventionActive Control1 Intervention
Group II: Delayed interventionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Nemours Children's Health SystemOTHER
9 Previous Clinical Trials
11,943 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,176,374 Total Patients Enrolled
Pediatric Emergency Care Applied Research NetworkNETWORK
5 Previous Clinical Trials
8,025 Total Patients Enrolled
David Brousseau, MD, MSPrincipal InvestigatorNemours Children's Health
1 Previous Clinical Trials
208 Total Patients Enrolled

Media Library

Care pathway Clinical Trial Eligibility Overview. Trial Name: NCT05373771 — N/A
Sickle Cell Crisis Research Study Groups: Post-intervention, Delayed intervention
Sickle Cell Crisis Clinical Trial 2023: Care pathway Highlights & Side Effects. Trial Name: NCT05373771 — N/A
Care pathway 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373771 — N/A
~1806 spots leftby Aug 2026