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Use of Intravenous magnesium sulphate in children with acute severe asthma

Intravenous Magnesium Sulphate as a second line therapy in children between 2 to 16 years admitted to PICU with acute severe asthma- A Randomised control trial. - none

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049011
Enrollment
40
Registered
2023-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Intravenous magnesium sulphate: Single dose of IV magnesium sulphate infusion 50 mg/kg over 30 minutes Control Intervention1: Intravenous aminophylline: IV aminophylline infusion as per

Sponsors

Surya Mother and Child Superspeciality hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children between 2- 16 years of age with moderate to severe acute asthma defined as PRAM (Pediatric respiratory assessment measure) score > 5 inspite of first line therapy with short acting beta agonists and corticosteroids.

Exclusion criteria

Exclusion criteria: 1. First episode of wheezing or alternative diagnosis like foreign body aspiration. 2. Coexisting pneumonia defined as radiological abnormalities like infiltrates or opacities on chest Roentgenogram. 3. Patients needing ventilator support. 4. Patients who have underlying cardiac, renal, neurologic or pulmonary dysfunction contraindicating the use of magnesium sulphate or aminophylline 5. Known hypersensitivity to Magnesium sulphate or aminophylline.

Design outcomes

Primary

MeasureTime frame
1. Reduction in asthma severity as measured by PRAM (Pediatric Respiratory Assessment Measure) score at 60 mins, 120 mins and 4 hours, 6 hrs, 12 hours and 24 hours after initiating therapy.Timepoint: 1. Reduction in asthma severity as measured by PRAM (Pediatric Respiratory Assessment Measure) score at 60 mins, 120 mins and 4 hours, 6 hrs, 12 hours and 24 hours after initiating therapy.

Secondary

MeasureTime frame
a. Length of ICU stay b. Duration of oxygen support c. Need for NIV d. Need for HFNC e. Need for invasive mechanical f. Mortality g. Adverse events such as tachycardia, GI bleeding, vomiting, need for vasoactive agents Timepoint: whole length of hospital stay

Countries

India

Contacts

Public ContactDr Pratik Sonje

Surya Mother and Child Superspeciality hospital, Pune

sshahdoc@gmail.com9689907296

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026