Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and 12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown that it has beneficial effect in treating acute asthma in children ; it reduces the hospital stay and the rate of admission as well as the ventilation rate .

Aim : To compare single dose Magnesium sulphate that is typically given in the emergency department verses two doses of magnesium sulphate in treating acute moderate-severe asthma exacerbation in paediatric age group Research hypothesis : Children who are treated with two doses MgSO4 are more likely to have improvement in their PRAM score and are less likely to be admitted to the ward, HD or ICU Primary outcome : Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation Secondary outcome : Reduce admission rate to general ward, PICU and HD . Demonstrate the safety profile of double dose of magnesium sulphate.

Study Design : prospective blinded randomized trial

Study population : children age 3-13 years who presented to Royal hospital paediatric emergency with moderate-severe acute asthma

Intervention : two doses magnesium sulphate

Comparison : Placebo

Outcome : Improvement in PRAM score

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oman Medical Speciality Board
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• Physican diagnosed of asthma

• Age 3-13 years

• Children presenting with acute moderate- severe asthma (PRAM score ≥ 5)

• Failed to respond to initial treatment of acute asthma

• Not known to have allergy from MgSO4

Exclusion Criteria:

• Mild exacerbation of asthma (initial PRAM score ≤4)

• Other comorbid present : Significant heart disease , arrhythmias , chronic kidney disease , cystic fibrosis , operated trachea-esophageal fistula , known or operated for vascular ring , trisomy 21