Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

NCT ID: NCT04929626

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-12

Brief Summary

In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.

Detailed Description

This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.

Conditions

Status Asthmaticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nebulized Ventolin

Nebulized Ventolin will given to 1st group after every 20 min for 1 hour

Group Type: ACTIVE_COMPARATOR

Ventolin

Intervention Type: DRUG

it will be given to control group in nebulized form after every 20 min in 1st hour

Nebulized Magnesium Sulphate + Ventolin

Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.

Group Type: EXPERIMENTAL

Magnesium Sulfate 500 mg/ml+ ventolin

Intervention Type: DRUG

3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form

Interventions

Magnesium Sulfate 500 mg/ml+ ventolin

3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form

Intervention Type: DRUG

Ventolin

it will be given to control group in nebulized form after every 20 min in 1st hour

Intervention Type: DRUG

Other Intervention Names

MgSO4; Salbutamol

Eligibility Criteria

Inclusion Criteria

1. Children between 2 to 12 years of age.

2. Children with the diagnosis of asthma having a pram score of more than 4.

3. Children with reactive airways

Exclusion Criteria

1. Critically ill children who require intubation or mechanical ventilation.

2. Having hypersensitivity or allergy to MgSO4.

3. with history of chronic lung impairment.

4. Whose parents are not giving informed consent for participation in research.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Dr.Rabia Asif

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia Asif, MBBS, PGT

Role: PRINCIPAL_INVESTIGATOR

Ziauddin Hospital

Locations

Rabia Asif

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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Related Links

https://pubmed.ncbi.nlm.nih.gov/21175517/

North American practice patterns of intravenous magnesium therapy in severe acute asthma in children

https://pubmed.ncbi.nlm.nih.gov/25652104/

Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial

https://pubmed.ncbi.nlm.nih.gov/27996280/

A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma

https://pubmed.ncbi.nlm.nih.gov/28153353/

The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4907636/

The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma

https://pubmed.ncbi.nlm.nih.gov/27220675/

Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial

https://pubmed.ncbi.nlm.nih.gov/24865567/

Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department

https://www.banglajol.info/index.php/FMCJ/article/view/25675

Nebulization by Isotonic Magnesium Sulphate Solution with Salbutamol Provide Early and Better Response as Compared to Conventional Approach (Salbutamol Plus Normal Saline) in Acute Exacerbation of Asthma in Children

https://pubmed.ncbi.nlm.nih.gov/24144222/

MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children

https://pubmed.ncbi.nlm.nih.gov/26955277/

Is ketamine a lifesaving agent in childhood acute severe asthma?

https://pubmed.ncbi.nlm.nih.gov/23218449/

An asthma management system in a pediatric emergency department

https://pjmd.zu.edu.pk/volume-9-issue-2/effectiveness-of-nebulized-magnesium-sulphate-as-an-adjuvant-therapy-with-salbutamol-in-the-management-of-acute-asthma/

Effectiveness of Nebulized Magnesium Sulphate as an Adjuvant Therapy (With Salbutamol) in the Management of Acute Asthma

https://pubmed.ncbi.nlm.nih.gov/26206872/

A summary of the new Global Initiative for Asthma (GINA) strategy: a roadmap to asthma control

https://pubmed.ncbi.nlm.nih.gov/31388549/

Management of asthma exacerbation in the emergency departments

https://pubmed.ncbi.nlm.nih.gov/28546381/

Adjunct Therapies for Refractory Status Asthmaticus in Children

https://pubmed.ncbi.nlm.nih.gov/29625590/

Guideline on management of the acute asthma attack in children by Italian Society of Pediatrics

https://pubmed.ncbi.nlm.nih.gov/24429154/

Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial

https://pubmed.ncbi.nlm.nih.gov/25394502/

Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4943055/

Contemporary treatment of children with critical and near-fatal asthma

Other Identifiers

Doses of Nebulized MgSO4

Identifier Type: -

Identifier Source: org_study_id