Nebulised Budesonide as an adjunct to standard first line therapy for emergency management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years age.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group
研究概览
简要总结
This study is a randomized, double blind, parallel group trial comparing the efficacy of addition of budesonide to nebulized salbutamol against standard therapy of only nebulized salbutamol for management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years presenting to the Paediatric emergency department. The primary outcome will be to measure the requirement for systemic corticosteroids at hour of admission .The secondary outcome will be to compare the effect of the intervention on improvement in Paediatric asthma severity score and duration of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children 2 to 18 years of age diagnosed to have an acute exacerbation of asthma.
- •The diagnosis will be based on the following criteria: 1.Children aged 2 to 18 years of age presenting to paediatric emergency with acute exacerbation of asthma having Paediatric asthma severity score of 8 to 15 And
- •Is a known case of childhood asthma or past history of at least two similar episodes in last 12 months relieved with bronchodilator therapy or already on controller therapy or with family history of asthma ,atopy ,nebulisations or personal history of atopic dermatitis, food allergy or allergic rhinitis.
排除标准
- •Presence of signs or symptoms suggestive of pneumonia, tuberculosis, heart disease croup, pertussis, measles, foreign body aspiration.
- •2.Documented fever >38 degrees Celsius 3.Life threatening exacerbation attack necessitating PICU admission and/or intubation owing to respiratory failure or depressed consciousness (GCS<8), and/or inotropes 4.Children enrolled in any other trial.
- •5.Children previously enrolled in this trial within last one month 6.Children who have received systemic corticosteroids for any indication within the previous 4weeks.
结局指标
主要结局
Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group
时间窗: One hour of presentation
次要结局
- Difference in mean reduction in Pediatric asthma severity score indicating clinical improvement at one hour of presentation
- Difference in mean duration of hospital stay in each group
研究者
Dr Jigyasa Goswami
Government Medical College and Hospital, Chandigarh