Effectiveness of Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Acute Asthma in Children in Suez Canal University Hospital Emergency Department: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Asthma is a problem that affects many children and affects their physical health in addition to having a social and financial burden on individuals, families and healthcare systems. In our pediatric emergency department, nebulizers are still used for the management of asthma and, with the poor resources of families, they have no option of treatment at home. In this study, the investigators will compare the effectiveness of treatment through nebulizer versus metered dose inhaler and spacer in children with an acute asthmatic attack seeking medical care at the Pediatric Emergency Department of Suez Canal University Hospital.
详细描述
Primary Objective:
To determine whether the administration of a B2 agonist by metered dose inhaler with spacer is as effective as the administration of B2 agonist by nebulizer for the treatment of an acute asthmatic episode in children seeking medical care in the Pediatric Emergency Department of Suez Canal University Hospital.
Secondary Objectives:
- Comparison of patients' visit duration in the ER room between the two groups.
- Comparison of hospitalization rate between the two groups.
- Comparison of parent/patient satisfaction between the two groups. Study design Single-blinded randomized control trial.
Study location This study will be conducted in the Pediatric Emergency Department in Suez Canal University Hospital.
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
- Single (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 ranging from 2 - 14 years old.
- •Both genders will be included.
- •Patients with an acute exacerbation of asthma.
排除标准
- •Patients with arrhythmia and cardiac diseases.
- •Patients with thyroid diseases.
- •Patients with bronchiolitis, pneumonia. Patients with status asthmaticus requiring immediate pediatric intensive care unit hospitalization.
研究组 & 干预措施
Nebulizer
Containing salbutamol
干预措施: Salbutamol (Drug)
Nebulizer
Containing salbutamol
干预措施: Nebulizer (Device)
Metered Dose Inhaler and spacer
Containing Salbutamol
干预措施: Salbutamol (Drug)
Metered Dose Inhaler and spacer
Containing Salbutamol
干预措施: Metered dose inhaler and spacer (Device)
结局指标
主要结局
Clinical improvement
时间窗: 1 hour
Clinical respiratory score change (see Study Protocol for details)
次要结局
- Patient satisfaction(1 hour)
- Rate of Hospitalization(4 hours)
研究者
Mona Azzam
Lecturer of Pediatrics
Suez Canal University