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Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

Primary Purpose

Acute Severe Asthma

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

isotonic magnesium sulphate

50% magnesium sulphate

About this trial

This is an interventional treatment trial for Acute Severe Asthma focused on measuring Magnesium sulphate nebulized

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Queen Sirikit National Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

isotonic magnesium sulphate

50% magnesium sulphate

Arm Description

2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval

magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Outcomes

Primary Outcome Measures

Asthma severity score

Secondary Outcome Measures

Length of stay in the hospital

Full Information

NCT ID

NCT02112305

First Posted

April 4, 2014

Last Updated

November 15, 2014

Sponsor

Queen Sirikit National Institute of Child Health

1. Study Identification

Unique Protocol Identification Number

NCT02112305

Brief Title

Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen Sirikit National Institute of Child Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Severe Asthma

Keywords

Magnesium sulphate nebulized

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

isotonic magnesium sulphate

Arm Type

Experimental

Arm Description

2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval

Arm Title

50% magnesium sulphate

Arm Type

Active Comparator

Arm Description

magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Intervention Type

Drug

Intervention Name(s)

isotonic magnesium sulphate

Other Intervention Name(s)

magnesium sulfate

Intervention Description

2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval

Intervention Type

Drug

Intervention Name(s)

50% magnesium sulphate

Other Intervention Name(s)

magnesium sulfate

Intervention Description

magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose

Primary Outcome Measure Information:

Title

Asthma severity score

Time Frame

60 minute

Secondary Outcome Measure Information:

Title

Length of stay in the hospital

Time Frame

within 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tassalapa Daengsuwan, Pediatrician

Organizational Affiliation

Queen Sirikit National Institute of Child Health

Official's Role

Study Director

Facility Information:

Facility Name

Queen Sirikit National Institute of Child Health

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

24144222

Citation

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 acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.

Results Reference

result

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Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

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