Comparison of effectiveness of Metered dose inhaler with spacer and Nebulizer in children aged 5-14 years with acute asthma: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Need for hospital admission
研究概览
简要总结
An informed written consent from parents will betaken. A randomizedcontrolled trial study design will be used. Subjects will be defined asasthmatic children aged 5-14 years who present to paediatric emergency withacute attack of asthma. With the help of computer generated randomization tablethe subjects will be divided into two groups. A sample size of 75 ineach group is taken. Enrolment number will be given toensure identity. Demographic data will be collected including name, father’sname, age, sex and address with phone number. Disease history will include theduration, severity of symptoms based on frequency of day and night symptoms,co-morbidities, family history and current treatment being received.Subjects in group 1 will receive Salbutamol with the helpof MDI and spacer (250ml) thrice at intervals of 20 minutes and subjects ingroup 2 will receive Salbutamol by oxygen driven nebulizer thrice at 20 minutesinterval. The subjects will be repeatedlyassessed to ensure clinical improvement. However, examination to record theparameters that will be used for the comparison of effectiveness by these twodevices will be conducted only four times during the observation period i.e.
- · Before giving any therapy
- · At 20 minutes duration
- · At 40 minutes duration
- · At 60 minutes duration.
The following parameters will be used for comparisonby using suitable statistical tests-
- 1. Respiratoryrate
- 2. Heartrate
- 3. Useof accessory muscles
- 4. Auscultatoryfindings
- 5. Peakexpiratory flow rate
- 6. Developmentof tremor
- 7. PaCO2on Venous Blood Gas Analysis
- 8. Needfor hospital admission
- 9. Durationof stay in emergency department
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged 5-14 years diagnosed with acute asthma.
排除标准
- •Non consenting child.
结局指标
主要结局
Need for hospital admission
时间窗: Need for hospital admission | Duration of stay in the emergency department
Duration of stay in the emergency department
时间窗: Need for hospital admission | Duration of stay in the emergency department
次要结局
- Respiratory Rate(Heart rate)
