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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06137040
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Asthma Attack
  • Asthma in Children

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium Sulfate within the first hour — DRUG
    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 — OTHER
    The control group will not receive IV magnesium sulfate within the first hour of treatment.

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
Dec 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Oklahoma Children's HospitalOklahoma CityOklahoma73104
Ryan McKee, MD
405-271-2429

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