Oklahoma Children's Hospital
Oklahoma City, Oklahoma, 73104, United States
Location status: Recruiting
NCT Number: NCT06137040
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.
Interested in participating?
Request Info5 year–17 year
All sexes
Interventional
Early Phase 1
Oklahoma City, Oklahoma, 73104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Magnesium within the first hour
The control group will not receive IV magnesium sulfate within the first hour of treatment.
Other names: No magnesium within the first hour
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jaclyn Urquiola Sorzano, DO
CONTACT
Ryan McKee, MD
CONTACT
University of Oklahoma
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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