Recruiting
Early Phase 1

Magnesium Sulfate

Sponsor:

University of Oklahoma

Code:

NCT06137040

Conditions

Asthma in Children

Asthma Attack

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Magnesium Sulfate within the first hour

No Magnesium sulfate within the first hour

Study Details

Brief summary:

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.

Conditions

Asthma in Children

Asthma Attack

Study ID

NCT06137040

Start date

Nov 30, 2023

Status verified date

Dec, 2024

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magnesium Sulfate in the first hour

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).

placebo comparator: No Magnesium Sulfate

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.

Interventions

Magnesium Sulfate within the first hour

The experimental group will receive 40-50 mg/kg of IV magnesium sulfate will be given to the experimental group alongside the first line asthma therapies (ie inhaled beta agonists, IV steroids). This will be given with a 20 mL/kg normal saline bolus (max 1000 mL) to avoid possible hypotension.

15-19 kg: 750 mg

20-29 kg: 1000 mg

30-39 kg: 1500 mg

>40 kg: 2000 mg

No Magnesium sulfate within the first hour

The control group will not receive IV magnesium sulfate within the first hour of treatment.

Primary outcome measure

  • Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group [ Time Frame: From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week ]

Central Contacts and Locations

Central contacts

Ryan McKee, MD

4056308997ryan-mckee@ouhsc.edu

Jaclyn Urquiola Sorzano, DO

7863906297jaclyn-urquiola@ouhsc.edu

Locations

Oklahoma Children's Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Ryan McKee, MD

405-271-2429Ryan-McKee@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • asthma exacerbation
  • magnesium sulfate
  • asthma
  • asthma attack

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-12-06.