Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

Ziauddin University

Status and phase: Completed; Phase 1

Conditions: Status Asthmaticus

Treatments: Drug: Magnesium Sulfate 500 mg/ml+ ventolin; Drug: Ventolin

Study type: Interventional

Funder types: Other

Identifiers

NCT04929626

Doses of Nebulized MgSO4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Nebulized Ventolin

Active Comparator group

Description:

Nebulized Ventolin will given to 1st group after every 20 min for 1 hour

Treatment:

Drug: Ventolin

Nebulized Magnesium Sulphate + Ventolin

Experimental group

Description:

Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.

Treatment:

Drug: Magnesium Sulfate 500 mg/ml+ ventolin