Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5-17
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 5-17 years old
Presents to the ED with a respiratory score in the "Moderate" range (6
Parent(s)/Caregiver(s) speak English
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Magnesium Sulfate within the first hour
DrugThe 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
Other interventionThe control group will not receive IV magnesium sulfate within the first hour of treatment.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Magnesium Sulfate in the first hourExperimental treatment 1 intervention
Group B: No Magnesium SulfatePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group
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
From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 weekSecondary outcomes
1
Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group
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.
Time frame
Time of initiation of therapy to discharge from the hospital, up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov