Comparison Of Efficacy Of Nebulised Levosalbutamol Vs Levosalbutamol Metered Dose Inhaler-Spacer: A Single Centre Open Label Randomized Controlled Trial In Hospitalized Children With Wheezing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- improvement in the pulmonary score.
研究概览
简要总结
Inhospital, nebuliser and MDI-spacer aretwo mainstay aerosol drug delivery method for β 2 agonists administration, but due to the lack of awarenessand lack of understanding of the inhalational technique MDI –spacer is notcommonly employed in the acute management. However,in clinical routine and under the supervision of trained proÂfessionals, theMDI-spacer technique may be just as effecÂtive as nebulisation. Although the efficacy of nebulization is broadly acknowledged, the method hasseveral disadvanÂtages. Studies show that nebulization may be ineffective indelivering aerosolized medicine compared to the combinaÂtion MDI-spacer.Incase of acute wheezing current guidelines recommend the use of short-actingbronchodilators (β 2 agonists) inhalation to reverse airflow obstruction andtreat patients. Thatbeing said, the purpose of this study is to comparethe efficacy of levosalbutamol aerosol therapy given via MDI-spacer to that givenvia nebulizer in hospitalised children with wheezing by using pulmonary score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children aged 1-12 year with acute wheezing and who will be admitted to Department of Pediatrics, Jaipur Golden Hospital.
- •2.Pulmonary score : 4-9( MODERATE TO SEVERE).
排除标准
- •Chronic lung disease -Cyanotic congenital heart disease -Suspected foreign body aspiration -Life threatening signs (altered sensorium, bradycardia, poor pulse volume, cyanosis, silent chest).
结局指标
主要结局
improvement in the pulmonary score.
时间窗: Improvement in the pulmonary score at 0 minute, 30 minute, 60 minute, 3 hour, 6 hour, 12 hour, 24hour.
次要结局
- Length of hospital stay.(Example. 24 hours)
