Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers
研究概览
简要总结
The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze
Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.
For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.
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 (Participant)
入排标准
- 年龄范围
- 6 Months 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6 to 24 months
- •Patients of both gender
- •Patients presenting to emergency department with bilateral wheeze
排除标准
- •Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).
- •Patients with history of congenital heart disease.
- •Patients with history of intubation for longer than 1 week during the neonatal period.
- •Patients having symptoms consistent with croup.
- •Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.
结局指标
主要结局
compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers
时间窗: 1 hour
primary outcome is defined as Comparison of mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers with spacers for treatment of wheezing in children aged 6 to 24 months in a pediatric emergency department
次要结局
未报告次要终点
研究者
Arooj Khan
Post Graduate Resident
Khyber Teaching Hospital
