Status Asthmaticus
Conditions
Keywords
asthma, nebulized, magnesium sulphate
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.
Interventions
DRUGMagnesium Sulfate 500 mg/ml+ ventolin
3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form
DRUGVentolin
it will be given to control group in nebulized form after every 20 min in 1st hour
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The principal investigator was aware of the intervention being provided. Others were masked including the participant and care provider.
Intervention model description
Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children between 2 to 12 years of age. 2. Children with the diagnosis of asthma having a pram score of more than 4. 3. Children with reactive airways
Exclusion criteria
1. Critically ill children who require intubation or mechanical ventilation. 2. Having hypersensitivity or allergy to MgSO4. 3. with history of chronic lung impairment. 4. Whose parents are not giving informed consent for participation in research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Scalene retractions | 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment | Absent (0) , Present (2) |
| 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 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | 24 hours | curtailment in the length of hospital stay |
Countries
Pakistan
Outcome results
None listed