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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form
it will be given to control group in nebulized form after every 20 min in 1st hour
Rabia Asif
Karachi, Sindh, Pakistan
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
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+).
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Suprasternal indrawing
Absent (0) , Present (2)
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Scalene retractions
Absent (0) , Present (2)
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Wheezing
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Air entry
Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Oxygen saturation on room air
\>93% (0), 90%-93% (1) or \<90% (2)
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
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Hospital stay
curtailment in the length of hospital stay
Time frame: 24 hours
Hospital stay
curtailment in the length of hospital stay
Time frame: 48 hours