Clinical trial NCT04929626: Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus
Official title: Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Status Asthmaticus
Keywords: asthma
nebulized
magnesium sulphate
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 126
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
measure: Change from baseline Suprasternal indrawing
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
measure: Change from baseline Scalene retractions
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
measure: Change from baseline Wheezing
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
measure: Change from baseline Air entry
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
measure: Change from baseline Oxygen saturation on room air
timeFrame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Secondary outcomes:
measure: Hospital stay
timeFrame: 24 hours
measure: Hospital stay
timeFrame: 48 hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Rabia Asif
state: Sindh
Study officials:
affiliation: Ziauddin Hospital
name: Rabia Asif, MBBS, PGT
role: PRINCIPAL_INVESTIGATOR
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