Early Magnesium Sulfate for Childhood Asthma

Phase < 1

Recruiting

Led By Ryan McKee, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of initiation of therapy to discharge from the hospital, up to 2 weeks

Summary

This trial is trying to find out if giving magnesium sulfate early to children with moderate asthma attacks can help prevent them from being admitted to the hospital, reduce the time they spend in the emergency room and hospital

Who is the study for?

This trial is for children aged 5-17 who come to the emergency department with a moderate level of breathing difficulty due to asthma. Their parents or caregivers must speak English. It's not suitable for those outside this age range or with different levels of respiratory distress.

What is being tested?

The study is testing if giving magnesium sulfate within the first hour of arriving at the hospital helps kids with moderate asthma attacks by reducing their stay in the ER, avoiding admission, and lessening the need for intensive care or breathing support.

What are the potential side effects?

Magnesium sulfate can cause side effects like flushing, sweating, nausea, vomiting, headache, dizziness, and sleepiness. In rare cases it might affect heart rate and blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of initiation of therapy to discharge from the hospital, up to 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of initiation of therapy to discharge from the hospital, up to 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of initiation of therapy to discharge from the hospital, up to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group

Secondary study objectives

Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Magnesium Sulfate in the first hourExperimental Treatment1 Intervention

These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids).

Group II: No Magnesium SulfatePlacebo Group1 Intervention

These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary.

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