Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation

University of Oklahoma (OU)

Status and phase: Enrolling; Early Phase 1

Conditions: Asthma Attack; Asthma in Children

Treatments: Drug: Magnesium Sulfate within the first hour; Other: No Magnesium sulfate within the first hour

Study type: Interventional

Funder types: Other

Identifiers

NCT06137040

16339

Details and patient eligibility

About

This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Full description

Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.

The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:

15-19 kg: 750 mg

20-29 kg: 1000 mg

30-39 kg: 1500 mg

>40 kg: 2000 mg

Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 5-17 years old
• Presents to the ED with a respiratory score in the "Moderate" range (6
• Parent(s)/Caregiver(s) speak English

Exclusion criteria

• Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients
• Patients who are pregnant
• Parent(s)/Caregiver(s) do not speak English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Magnesium Sulfate in the first hour

Experimental group

Description:

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).

Treatment:

Drug: Magnesium Sulfate within the first hour

No Magnesium Sulfate

Placebo Comparator group

Description:

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.

Treatment:

Other: No Magnesium sulfate within the first hour