Asthma Attack, Asthma in Children
Conditions
Keywords
asthma exacerbation, magnesium sulfate, asthma, asthma attack
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.
Detailed 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.
Interventions
DRUGMagnesium 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
OTHERNo Magnesium sulfate within the first hour
The control group will not receive IV magnesium sulfate within the first hour of treatment.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Since the study is randomized, the participant and the provider will not know which group the enrolled patient will be in until the patient is randomized to a group.
Intervention model description
Experiment group will receive magnesium sulfate within the first hour with all of the other first line treatments vs. control group will not receive magnesium sulfate within the first hour of treatment.
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group | From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week | Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can reduce length of stay in the ED, general hospital bed or PICU. The data will also be analyzed to determine if more patients in the experimental group were able to be discharged from the emergency department compared to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group | Time of initiation of therapy to discharge from the hospital, up to 2 weeks | Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can decrease the need for respiratory support including invasive and non-invasive respiratory support devices. |
Countries
United States
Contacts
Primary ContactRyan McKee, MD
Backup ContactJaclyn Urquiola Sorzano, DO
Outcome results
None listed