None listed
Conditions
Brief summary
Asthma attacks are a common reason children come to the Emergency Department. When inhaled treatments and steroids are not enough, doctors give stronger medicines through a drip. The two medicines used most often are magnesium and aminophylline, but despite their frequent use, we still don’t know which one helps children recover faster or reduces the need for extra breathing support. The MAGIC study will compare these two treatments in more than 1,000 children aged 2 to 15 years with severe asthma across leading hospitals in Australia and Aotearoa New Zealand. Each child will be randomly assigned to receive one of the medicines first; if their asthma remains severe, they may also receive the other. We will measure whether the first medicine works within four hours without needing more IV treatment or increased breathing support, and which treatment pathway leads to shorter hospital stays. We will also assess side effects, need for intensive care, satisfaction with care, quality of life and costs. The aim is to provide clear evidence to guide emergency doctors and update national guidelines in both countries, helping children recover more quickly and return home sooner.
Interventions
Drug name: Intravenous magnesium sulfate (MgSO4)
Children receive intravenous magnesium sulfate (MgSO4), an IV bronchodilator used when inhaled treatments are insufficient for acute severe asthma. The dose is 0.2 mmol/kg (50 mg/kg), maximum 10 mmol, diluted to 50 mL and administered as a 30-minute IV infusion (0.4 mL/kg) via a standard Emergency Department IV line. The medication (International Non-proprietary Name: magnesium sulfate) is supplied in blinded 20 mL vials labelled MAGIC study medic
Drug name: Intravenous magnesium sulfate (MgSO4) Children receive intravenous magnesium sulfate (MgSO4), an IV bronchodilator used when inhaled treatments are insufficient for acute severe asthma. The dose is 0.2 mmol/kg (50 mg/kg), maximum 10 mmol, diluted to 50 mL and administered as a 30-minute IV infusion (0.4 mL/kg) via a standard Emergency Department IV line. The medication (International Non-proprietary Name: magnesium sulfate) is supplied in blinded 20 mL vials labelled MAGIC study medication A or MAGIC study medication B. A single infusion is given at randomisation. If further parenteral bronchodilator treatment is required while the child remains in the Emergency Department, they receive the alternate blinded medication (aminophylline). No dose titration or individual tailoring occurs. If the child has left the Emergency Department when additional treatment is needed, subsequent parenteral therapy is determined by the treating clinical team. Drug name: Intravenous aminophylline Children receive intravenous aminophylline (International Non-proprietary Name: aminophylline) as an IV bronchodilator when inhaled therapy is insufficient. The dose is 10 mg/kg, maximum 500 mg, diluted to 50 mL and administered as a 30-minute IV infusion (0.4 mL/kg) via a standard Emergency Department IV line. The medication is supplied in blinded 20 mL vials labelled MAGIC study medication A or MAGIC study medication B. A single infusion is given at randomisation. If further parenteral bronchodilator treatment is required while the child remains in the Emergency Department, they receive the alternate blinded medication (magnesium sulfate). As above, no dose titration occurs, and any additional treatment after leaving the Emergency Department is determined by the treating clinical team. Both medications are supplied in identical blinded vials and prepared using the same dilution and infusion procedure to maintain blinding. Emergency Department clinicians administer all infusions according to a standardised protocol, and drug accountability logs and monitoring procedures are used to ensure adherence.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
(i) child aged from 2 (2 years and 0 days) to 15 years (up to 15 years + 364 days); (ii) receiving ED care for severe exacerbation of asthma / wheeze; and (iii) ED-based treating clinical team determines that IV bronchodilator therapy is required; and (iv) IV access is secured.
Exclusion criteria
(i) patient has already received IV bronchodilators (e.g. salbutamol, MgSO4 or aminophylline) for this exacerbation; (ii) peri-arrest or requiring immediate non-invasive ventilation, where multiple parenteral therapies are planned simultaneously; (iii) allergy to or contraindications to study medication; (iv) suspected anaphylaxis; (v) patient-specific ED management plan dictating choice of IV bronchodilator; (vi) child is under care of child protection services; (vii) child presents with parents/guardians who require an interpreter and an appropriate interpreter is not readily available; or (viii) previous study enrolment.
Outcome results
None listed