Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics

Research questions :

In children 3 to 13 years of age presenting to the pediatric emergency room with moderate to severe asthma exacerbation, does double dose Magnesium sulfate improve asthma severity (PRAM) score and reduce admission rate more than single dose?

Study design :

Prospective double-blinded randomized clinical trial in paediatric (from age 3-13 years) who presents to the emergency department (ED) at Sultan Royal hospital with moderate to severe Acute asthma (PRAM score >=5) , Consent will be obtained from the parents. Eligible subjects will be enrolled Control Group Will receive second dose magnesium sulphate (50 mg/kg over 1 hour = 2.5mllkg) Intervention Group Will receive Normal saline (2.5ml/kg over 1 hour )

Sample size:

90 patient will be needed ( 45 on each arm) to have 60% power to detect a difference on PRAM score between the groups at the 5% alpha (significance) level.

Study steps:

1. Initial nursing triage for all acute asthma exacerbation , initial PRAM score will be recorded
2. Initial standard management as per protocol , which includes :
3. Oxygen if indicated
4. Back to back salbutamol (2.5-5 mg) and ipratropium (0.25-0.5 mg )nebulization OR salbutamol MDI 5 puffs (wt 10 Kg) -
5. Systemic corticosteroid : children with PRAM 5-8 give oral dexamethasone 0.3 mg/kg , those with PRAM score 9-12 give hydrocortisone 4 mg/kg IV
6. Child will reassessed after the initial measures , PRAM score will be recorded in the patient sheet
7. All children with persistent PRAM score of ≥ 5 will receive the first dose of magnesium sulphate ( 50 mg/kg over 20 minutes
8. After 30 minutes of the first dose Magnesium sulphate PRAM score will be recorded, during this period child will be given 20ml/hr normal saline
9. Children with persistent PRAM score ≥ 5 will be included in the study provided they met the inclusion and exclusion criteria (as mentioned below ) ,consent will be obtained from parents
10. If the child met the inclusion and exclusion criteria , the treating physician will pick one envelope from the research box , each envelope will have serial or sequencing number for the medications (saline or MgSO4 )
11. The pharmacist will prepare a 100 ml bags that contains either saline or 2 grams magnesium sulphate in 100ml. The content will be concealed from the treating physician by the pharmacist.
12. Child be will given 2.5 ml/kg from any bag chosen (based on the sequencing) . The total amount will be infused over one hour.
13. PRAM score post intervention will be recorded . Disposition will be based on physician assessment and improvement in PRAM score
14. Safety Assessments : All adverse events will be documented on an side effect section on patient's sheet case . Serious adverse events should be immediately reported to the primary investigator. Any serious, adverse event will be reported immediately to the Institutional Review Board.

Reported side effects for magnesium sulphte : nausea ,facial warmth , flushing , pain and numbness at infusion site , dry mouth and malaise . Rare side effect : hypotension

Beneficiaries of the research :

• To the child :
• Improvement in his/her symptoms
• Reduce PICU admission and intubation
• Reduce the abstinences from school and improve the quality of life
• To the health system:
• Availability of PICU and HDU beds for more sick patients
• Reducing the cost of asthmatic patient care