Single Versus Double Dose Magnisum Sulphate in the Treatment of Moderate to Severe Asthma in Children in the Emergency Department
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 主要终点
- Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma
研究概览
简要总结
Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and 12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown that it has beneficial effect in treating acute asthma in children ; it reduces the hospital stay and the rate of admission as well as the ventilation rate .
Aim : To compare single dose Magnesium sulphate that is typically given in the emergency department verses two doses of magnesium sulphate in treating acute moderate-severe asthma exacerbation in paediatric age group Research hypothesis : Children who are treated with two doses MgSO4 are more likely to have improvement in their PRAM score and are less likely to be admitted to the ward, HD or ICU Primary outcome : Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation Secondary outcome : Reduce admission rate to general ward, PICU and HD . Demonstrate the safety profile of double dose of magnesium sulphate.
Study Design : prospective blinded randomized trial
Study population : children age 3-13 years who presented to Royal hospital paediatric emergency with moderate-severe acute asthma
Intervention : two doses magnesium sulphate
Comparison : Placebo
Outcome : Improvement in PRAM score
详细描述
Research questions :
In children 3 to 13 years of age presenting to the pediatric emergency room with moderate to severe asthma exacerbation, does double dose Magnesium sulfate improve asthma severity (PRAM) score and reduce admission rate more than single dose?
Study design :
Prospective double-blinded randomized clinical trial in paediatric (from age 3-13 years) who presents to the emergency department (ED) at Sultan Royal hospital with moderate to severe Acute asthma (PRAM score >=5) , Consent will be obtained from the parents. Eligible subjects will be enrolled Control Group Will receive second dose magnesium sulphate (50 mg/kg over 1 hour = 2.5mllkg) Intervention Group Will receive Normal saline (2.5ml/kg over 1 hour )
Sample size:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physican diagnosed of asthma
- •Age 3-13 years
- •Children presenting with acute moderate- severe asthma (PRAM score ≥ 5)
- •Failed to respond to initial treatment of acute asthma
- •Not known to have allergy from MgSO4
排除标准
- •Mild exacerbation of asthma (initial PRAM score ≤4)
- •Other comorbid present : Significant heart disease , arrhythmias , chronic kidney disease , cystic fibrosis , operated trachea-esophageal fistula , known or operated for vascular ring , trisomy 21
研究组 & 干预措施
Second dose magnesium sulphate
Second dose magnesium sulphate 50 mg/kg infused over one hour
干预措施: Magnesium Sulfate (Drug)
Placebo
Normal saline (2.5 ml/kg) infused over one hour
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma
时间窗: at 60 minutes of intervention
Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation
次要结局
- Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit(during first 24 hours)
- Demonstrate the safety profile of double dose of magnesium sulphate.(during first 24 hours)
研究者
Noora Nasser Al-Alawi
Emergency resident -Oman medical specialty board
Oman Medical Speciality Board