Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose With/Without Nebulized Budesonide for the Emergency Management of the Severe Asthma. A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Time to medical readiness for discharge.
研究概览
简要总结
Many studies have investigated the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids in addition to the standard treatment for patients with severe asthma attacks.
In this 2x2 factorial design blinded randomized study, no interaction of hypothesized treatments is expected.Investigators hypothesize that two doses of intravenous magnesium sulfate,a high dose followed by a (lower) standard dose, will shorten the time to medical readiness for discharge compared to a single standard dose followed by placebo.The second hypothesis is that nebulized inhaled budesonide will be superior to placebo.
详细描述
Patient with a severe asthma attack will be admitted to the observation area in the Pediatric Emergency Center and assessed for eligibility for the study by the attending physician, based upon our study inclusion/exclusion criteria.
Eligible patients will be enrolled after obtaining written consent from the parents. Patients will receive routine treatment for a severe asthma attack, such as inhaled bronchodilators, plus intravenous steroids and supplementary oxygen if needed. Standard blood work and chest X-Ray will be obtained and bronchial asthma severity score will be measured at baseline before starting treatment,and then at 4,8,12,24,36,48 hr and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. The patient will be randomized into one of the four study groups and adverse effects of the medications in each group will be monitored and documented carefully.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 2-14 years of age.
- •Known to have bronchial asthma.
- •Presenting in severe asthma exacerbation
- •Asthma severity score 8 or higher according to PRAM asthma severity .
排除标准
- •Prematurity <34 weeks of gestation.
- •Critically ill children requiring immediate intubation or ICU admission.
- •Transfers from other institutions.
- •Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
- •History of neuromuscular disease, cardiac disease, renal disease, liver disease.
- •Underlying chronic lung disease.
- •Radiographic evidence of pneumonia or lung collapse .
- •Hemodynamic instability.
- •Instrumented airway or Tracheotomy.
- •Colostomy or ileostomy.
- •Malabsorption disorder.
- •Known vitamin D deficiency.
- •Receiving Milk of Magnesium for Constipation
- •Chronic diarrhea (duration for 2 weeks)
- •Diuretics use.
- •Immunodeficiency.
研究组 & 干预措施
Hi-Mg + Bud
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
干预措施: Hi-dose iv MgSO4 (Drug)
Hi-Mg + Bud
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
干预措施: Nebulized budesonide (Drug)
Hi-Mg + P
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
干预措施: Hi-dose iv MgSO4 (Drug)
Hi-Mg + P
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
干预措施: Nebulized normal saline (Drug)
Std-Mg + Bud
Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.
干预措施: Nebulized budesonide (Drug)
Std-Mg + Bud
Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.
干预措施: Std-dose iv MgSO4 (Drug)
St-Mg + P
Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline
干预措施: Std-dose iv MgSO4 (Drug)
St-Mg + P
Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline
干预措施: Nebulized normal saline (Drug)
结局指标
主要结局
Time to medical readiness for discharge.
时间窗: 3 years
The aim of the study is to find out if the two doses of intravenous magnesium sulfate 100 mg/kg followed by 50 mg/kg with or without nebulized budesonide would shorten the length of the emergency center's stay in comparison to the 50 mg/kg dose with or without nebulized budesonide in treating severe asthma attack in children, who are admitted to the pediatric emergency center Al-Sadd, in a double blinded randomized controlled trial. .
次要结局
- Comparison of clinical response in severity score (%)(3 years)
- Overall length of the hospital stay (hours/days) .(3 years)
- The rate of admission to pediatric intensive care unit (%)(3 years)
- Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)(3 years)