跳至主要内容
临床试验/NCT06201156
NCT06201156已完成不适用

Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze

Khyber Teaching Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年12月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arooj Khan

Post Graduate Resident

Khyber Teaching Hospital

研究点 (2)

Loading locations...

相似试验