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Trial record 22 of 36 for:    "Status Asthmaticus"

Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02112305
Recruitment Status : Unknown
Verified November 2014 by Tassalapa Daengsuwan, Queen Sirikit National Institute of Child Health.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Tassalapa Daengsuwan, Queen Sirikit National Institute of Child Health

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

Condition or disease Intervention/treatment Phase
Acute Severe Asthma Drug: isotonic magnesium sulphate Drug: 50% magnesium sulphate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma
Study Start Date : January 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: isotonic magnesium sulphate
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval
Drug: isotonic magnesium sulphate
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval
Other Name: magnesium sulfate

Active Comparator: 50% magnesium sulphate
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose
Drug: 50% magnesium sulphate
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose
Other Name: magnesium sulfate




Primary Outcome Measures :
  1. Asthma severity score [ Time Frame: 60 minute ]

Secondary Outcome Measures :
  1. Length of stay in the hospital [ Time Frame: within 2 weeks ]


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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112305


Locations
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Thailand
Queen Sirikit National Institute of Child Health
Bangkok, Thailand, 10400
Sponsors and Collaborators
Queen Sirikit National Institute of Child Health
Investigators
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Study Director: Tassalapa Daengsuwan, Pediatrician Queen Sirikit National Institute of Child Health

Publications of Results:
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Responsible Party: Tassalapa Daengsuwan, medical doctor, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier: NCT02112305     History of Changes
Other Study ID Numbers: EC 104/2557
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Tassalapa Daengsuwan, Queen Sirikit National Institute of Child Health:
Magnesium sulphate nebulized

Additional relevant MeSH terms:
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Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents