Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 5-17 years old
- •Presents to the ED with a respiratory score in the "Moderate" range (6
- •Parent(s)/Caregiver(s) speak English
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Magnesium Sulfate within the first hour (Drug)
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.
干预措施: No Magnesium sulfate within the first hour (Other)
结局指标
主要结局
Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group
时间窗: 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.
次要结局
- 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)