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Published on: November 9, 2016
Intravenous Magnesium: Prompt use for Asthma in Children Treated in the Emergency Department (IMPACT-ED), a pilot
Michael D Johnson1, Bashar S Shihabuddin2, Bradley J Barney3
1Division of Pediatric Emergency Medicine, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Insights
This pilot study evaluated intravenous magnesium sulfate (IVMg) for severe childhood asthma. While feasible, enrollment and timely drug delivery need improvement for larger trials.
Area of Science:
- Pediatric Emergency Medicine
- Pharmacology
- Clinical Trials
Background:
- Asthma is a leading chronic illness in children, causing significant hospitalizations and healthcare costs.
- Intravenous magnesium sulfate (IVMg) shows potential for treating severe acute asthma in children, possibly reducing emergency department (ED) admissions.
- A large-scale trial is needed to confirm IVMg's efficacy, but a pilot study is required to refine procedures.
Purpose of the Study:
- To assess the feasibility of conducting a large multicenter trial on IVMg for severe acute childhood asthma.
- To evaluate the procedures for drug delivery, patient monitoring (hypotension), and sample collection.
- To gather data for planning a future definitive trial.
Main Methods:
- A multicenter, double-blind, controlled pilot trial involving children aged 2-17 with severe acute asthma.
- Randomization to placebo, low-dose IVMg, or high-dose IVMg, administered alongside standard ED asthma therapy.
- Feasibility assessment focused on study drug delivery within 90 minutes, blood pressure monitoring, and blood sample acquisition.
Main Results:
- 52 patients were randomized; 49 received study drug. Median age was 6.3 years; 67.3% were male.
- Study drug delivery within 90 minutes occurred in 65.4% of participants.
- Blood pressure measurements (89.7%) and blood samples (88.5%) were obtained within target timeframes. Hypotension rates were similar between placebo (11.1%) and IVMg (6.5%) groups.
Conclusions:
- The pilot trial demonstrated feasibility in obtaining measurements and samples, with acceptable hypotension rates.
- Lower-than-anticipated enrollment and challenges with timely study drug delivery were identified.
- These findings necessitate adjustments for planning a larger, definitive multicenter trial on IVMg for pediatric asthma.
Background:
Asthma is the most common chronic illness of childhood and a leading cause of hospitalization and health care costs for children. Intravenous magnesium sulfate (IVMg) may help severely ill children avoid hospitalization when added to standard treatment in an emergency department (ED), but this has not been adequately evaluated in a large trial. We conducted a pilot trial to test procedures and gather information to plan a large multicenter trial.
Methods:
Children 2-17 years old with severe acute asthma were randomized in a multicenter, double-blind, controlled trial of placebo (saline, 1 mL/kg, max 40 mL), low-dose IVMg (50 mg/kg, max 2 g), or high-dose IVMg (75 mg/kg, max 3 g) in addition to standard asthma therapy at the EDs of three tertiary pediatric hospitals between September 2022 and May 2023. We assessed the feasibility of delivering study drug within 90 min of treatment (defined as the start of the first inhaled albuterol) and monitoring for hypotension and obtained blood samples for pharmacologic analysis. Our target enrollment was one participant per site per week (90 total).
Results:
A total of 52 patients were randomized, and 49 received study drug. Median (Q1, Q3) participant age was 6.3 (4.6, 9.6) years and 35 (67.3%) were male. Among 52 randomized participants, study drug was delivered within 90 min to 34 (65.4%), 486/542 (89.7%) anticipated blood pressure measurements were within time frames, 138/156 (88.5%) anticipated blood samples were obtained, and 38 (73.1%) were hospitalized. Hypotension was measured within 2 h of study drug administration in 2/18 (11.1%) who received placebo and 2/31 (6.5%) who received IVMg.
Conclusions:
Most anticipated blood pressure measurements and blood samples were obtained. Hypotension occurred at rates similar to previous reports. Lower-than-expected enrollment (related to low patient volumes) and timely delivery of study drug will require consideration for a larger trial.
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