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Comparing the effectiveness of Intravenous Vs Nebulised Magnesium sulphate among children aged 2-12 years who do not respond to the initial treatment of Acute Severe Asthma, admitted to National Hospital Galle. A Randomised Controlled Clinical Trial: MAGRU study

Comparing the effectiveness of Intravenous Vs Nebulised Magnesium sulphate among children aged 2-12 years who do not respond to the initial treatment of Acute Severe Asthma, admitted to National Hospital Galle. A Randomised Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2026/005
Enrollment
Unknown
Registered
2026-02-22
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

Study setting: Emergency Treatment Unit at National Hospital, Galle. Randomization: a. Method of randomization : Block randomisation according to gender. b. Unit of randomization: Individual c. Meth
sequentially numbered, opaque, sealed envelopes Intervention: Both groups will receive back-back nebulization with salbutamol, which is the standard therapy outlined in the GINA guidelines. Thereaft
2.5 ml of isotonic solution
if failing to respond will be moved to intravenous magnesium sulphate. Control: Intravenous magnesium sulphate 40mg/kg over 20 minutes, when not responding to back-back nebulization with salbutamol,

Sponsors

Faculty of Medicine, University of Ruhuna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both male and female The children aged between 2-12 years Pediatrician diagnosed Acute Severe Asthma; PRAM ( Pediatric Respiratory Assessment Measures) score between 8-12

Exclusion criteria

Exclusion criteria: The children admitted with mild- moderate asthma with PRAM score less than 8 The children with heart failure The children with chronic lung disease other than asthma The children who have diagnosed structural lung diseases such as Congenital cystic adenomatous malformation, congenital lobar emphysema, diaphragmatic hernia etc The children who have medical conditions that mimic respiratory distress eg; metabolic diseases, laryngo tracheomalacia etc

Design outcomes

Primary

MeasureTime frame
PRAM score (Pediatric Respiratory Assessment Measures) [Fifteen minutes after the completion of the intervention, either with nebulised or intravenous magnesium sulphate ]

Secondary

MeasureTime frame
Side effects of nebulised magnesium - Hypotension Tachycardia Diminished tendon reflexes [15-20 minutes after the initial intervention with intravenous or nebulised magnesium sulphate Those who failed to improve with nebulised MgSO4 will again be assessed 15-20 minutes after the intravenous magnesium sulphate . ]

Countries

Sri Lanka

Contacts

Public ContactPushpika Prabashini Jayawardana

Associate professor

pushpikaja@yahoo.com.au0912246879

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026