Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus
- Conditions
- Status Asthmaticus
- Interventions
- Drug: Magnesium Sulfate 500 mg/ml+ ventolin
- Registration Number
- NCT04929626
- Lead Sponsor
- Ziauddin University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Children between 2 to 12 years of age.
- Children with the diagnosis of asthma having a pram score of more than 4.
- Children with reactive airways
- Critically ill children who require intubation or mechanical ventilation.
- Having hypersensitivity or allergy to MgSO4.
- with history of chronic lung impairment.
- Whose parents are not giving informed consent for participation in research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nebulized Magnesium Sulphate + Ventolin Magnesium Sulfate 500 mg/ml+ ventolin Dose of Nebulized Magnesium sulphate will vary in 3 subgroups. Nebulized Ventolin Ventolin Nebulized Ventolin will given to 1st group after every 20 min for 1 hour
- Primary Outcome Measures
Name Time Method Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline 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 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment Absent (0) , Present (2)
Change from baseline Scalene retractions 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment Absent (0) , Present (2)
Change from baseline Wheezing 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 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 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment \>93% (0), 90%-93% (1) or \<90% (2)
- Secondary Outcome Measures
Name Time Method Hospital stay 48 hours curtailment in the length of hospital stay
Trial Locations
- Locations (1)
Rabia Asif
🇵🇰Karachi, Sindh, Pakistan