Overview

This trial is active, not recruiting.

Condition acute severe asthma
Treatments isotonic magnesium sulphate, 50% magnesium sulphate
Sponsor Queen Sirikit National Institute of Child Health
Start date January 2014
End date May 2015
Trial size 40 participants
Trial identifier NCT02112305, EC 104/2557

Summary

The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval
isotonic magnesium sulphate magnesium sulfate
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval
(Active Comparator)
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose
50% magnesium sulphate magnesium sulfate
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Primary Outcomes

Measure
Asthma severity score
time frame: 60 minute

Secondary Outcomes

Measure
Length of stay in the hospital
time frame: within 2 weeks

Eligibility Criteria

Male or female participants from 2 years up to 15 years old.

Inclusion Criteria: - Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy Exclusion Criteria: - chronic lung disease - history of adverse reaction form magnesium sulphate - life threatening condition

Additional Information

Official title Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma
Description Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Queen Sirikit National Institute of Child Health.