Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
研究概览
简要总结
In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.
详细描述
This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.
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
- Double (Participant, Care Provider)
盲法说明
The principal investigator was aware of the intervention being provided. Others were masked including the participant and care provider.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2 to 12 years of age.
- •Children with the diagnosis of asthma having a pram score of more than
- •Children with reactive airways
排除标准
- •Critically ill children who require intubation or mechanical ventilation.
- •Having hypersensitivity or allergy to MgSO
- •with history of chronic lung impairment.
- •Whose parents are not giving informed consent for participation in research.
研究组 & 干预措施
Nebulized Ventolin
Nebulized Ventolin will given to 1st group after every 20 min for 1 hour
干预措施: Ventolin (Drug)
Nebulized Magnesium Sulphate + Ventolin
Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.
干预措施: Magnesium Sulfate 500 mg/ml+ ventolin (Drug)
结局指标
主要结局
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+).
Change from baseline Suprasternal indrawing
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
Change from baseline Scalene retractions
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
Change from baseline Wheezing
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry
Change from baseline Air entry
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)
Change from baseline Oxygen saturation on room air
时间窗: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
\>93% (0), 90%-93% (1) or \<90% (2)
次要结局
- Hospital stay(48 hours)
研究者
Dr.Rabia Asif
Principal investigator
Ziauddin University