Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

Acute Severe Asthma Clinical Trial

Official title:

Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02112305
• Other study ID #: EC 104/2557
• Status: Active, not recruiting
• Phase: N/A
• First received: April 4, 2014
• Last updated: November 15, 2014
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: Queen Sirikit National Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Severe Asthma
• Status Asthmaticus

Intervention

Drug:
• isotonic magnesium sulphate
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval
• 50% magnesium sulphate
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Locations

Country	Name	City	State
Thailand	Queen Sirikit National Institute of Child Health	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Queen Sirikit National Institute of Child Health

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma severity score		60 minute	Yes
Secondary	Length of stay in the hospital		within 2 weeks	No