Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department
Purpose
This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.
Condition
- Asthma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults ≥18 years old presenting to the ED with an asthma exacerbation - Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician - Discharged from the ED with a primary diagnosis of asthma exacerbation - Initiated systemic corticosteroids during the ED visit - Must be English or Spanish speaking
Exclusion Criteria
- Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival - History of severe adverse reactions to corticosteroids - Heart failure and uncontrolled diabetes (glucose >300mg/dL in the ED) - Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population - Inability to provide informed consent
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Participants, treating physicians, nursing, and the investigators will remain blinded to treatment allocation. Blinded medications will be pre-packaged by the clinical research pharmacy team.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Single Intramuscular Steroid Injection |
Dexamethasone 16mg Intramuscular Single Dose |
|
|
Active Comparator Oral Steroid Short Course |
Prednisone 60mg PO for 5 Days |
|
Recruiting Locations
The Bronx, New York 10467
More Details
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
Detailed Description
Asthma exacerbations are a leading cause of emergency department (ED) visits in the United States. In pediatric patients, a single dose of dexamethasone has been widely adopted as an effective and convenient alternative to multi-day oral steroid regimens. However, in adults, evidence regarding the efficacy of a single-dose steroid approach compared to a traditional 5-day course of oral prednisone is mixed. Despite the availability of oral corticosteroids like prednisone, medication adherence after ED discharge remains a significant challenge. Studies indicate that only about 30% of ED patients fill prescribed medications post-discharge. A single-dose intramuscular (IM) dexamethasone regimen offers the advantage of ensuring adequate anti-inflammatory effects for asthma exacerbations. This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations.