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Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

NCT ID: NCT02112305

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Acute Severe Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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isotonic magnesium sulphate

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

Group Type EXPERIMENTAL

isotonic magnesium sulphate

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

50% magnesium sulphate

Intervention Type DRUG

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

Interventions

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isotonic magnesium sulphate

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

Intervention Type DRUG

50% magnesium sulphate

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

Intervention Type DRUG

Other Intervention Names

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magnesium sulfate magnesium sulfate

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Sirikit National Institute of Child Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tassalapa Daengsuwan

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tassalapa Daengsuwan, Pediatrician

Role: STUDY_DIRECTOR

Queen Sirikit National Institute of Child Health

Locations

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Queen Sirikit National Institute of Child Health

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 24144222 (View on PubMed)

Other Identifiers

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EC 104/2557

Identifier Type: -

Identifier Source: org_study_id