Home » Trials » SLCTR/2026/005
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
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SLCTR Registration Number
SLCTR/2026/005
Date of Registration
The date of last modification
Feb 23, 2026
Scientific Title of Trial
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
Public Title of Trial
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
Disease or Health Condition(s) Studied
Bronchial asthma
Scientific Acronym
None
Public Acronym
MAGRU
Brief title
Comparing the effectiveness of intravenous Vs nebulised Magnesium sulphate among children aged 2-12 years with Acute Severe Asthma, A Randomised Controlled Clinical Trial
Universal Trial Number
U1111-1332-3790
Any other number(s) assigned to the trial and issuing authority
ERC number - 2024/P/015
What is the research question being addressed?
Is nebulised magnesium sulphate more effective in treating acute severe asthma, compared to intravenous magnesium sulphate, in children aged 2-12 years who do not respond to the initial management?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
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. Method of sequence generation: Computer-generated random number table. d. Method of allocation concealment; 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. Thereafter, the study group will receive nebulised magnesium sulphate solution with 150mg magnesium sulphate;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,
Blinding: data collectors outcome adjudicators data analysts
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
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
Primary outcome(s)
|
1.
PRAM score (Pediatric Respiratory Assessment Measures) |
[ Fifteen minutes after the completion of the intervention, either with nebulised or intravenous magnesium sulphate ] |
Secondary outcome(s)
|
1.
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 . ] |
Target number/sample size
116 - 58 children in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2026-03-01
Anticipated end date
2026-12-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2025-01-28
Approval number
2024/P/015
Details of Ethics Review Committee
| Name: | Ethical Review Committee , Faculty Of Medicine, University of Ruhuna |
| Institutional Address: | P.O. Box 70, Inland Hill Road, Karapitiya, Galle. |
| Telephone: | +9491 2234801 |
| Email: | dean@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Pushpika Prabashini Jayawardana
Associate professor
Department of Paediatrics, Faculty of Medicine, University of Ruhuna
0912246879
+94777901662
+94 91 2222314
pushpikaja@yahoo.com.au
www.medi.ruh.ac.lk
Contact Person for Public Queries
Pushpika Prabashini Jayawardana
Associate professor
Department of Paediatrics, Faculty of Medicine, University of Ruhuna
0912246879
+94777901662
+94 91 2222314
pushpikaja@yahoo.com.au
www.medi.ruh.ac.lk
Primary study sponsor/organization
Faculty of Medicine, University of Ruhuna
PO Box 70,
Galle,
Sri Lanka.
+94 91 2234801, +94 91 2234803
+94 91 2222314
dean@med.ruh.ac.lk
https://www.medi.ruh.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
What data will be shared? - All of the individual participant data collected during the trial, after de-identification. Data will be available immediately following publication, no end date. The data will be shared based on the objectives in the approved proposal. Data will be available on reasonable request to principal investigator.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
