Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma

NCT ID: NCT04497766

Last Updated: 2021-02-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nebulized magnesium sulphate

100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer

Group Type EXPERIMENTAL

Nebulized Magnesium sulfate

Intervention Type DRUG

MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes

Intravenous magnesium sulphate

Magnesium sulphate according to weight will be given intravenously.

Group Type EXPERIMENTAL

Intravenous magnesium sulphate

Intervention Type DRUG

pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nebulized Magnesium sulfate

MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes

Intervention Type DRUG

Intravenous magnesium sulphate

pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nebulized MgSO4 IV MgSO4

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes

Exclusion Criteria

* those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Edward Medical University

OTHER

Sponsor Role collaborator

Saima Khatoon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saima Khatoon

Post Graduate Resident in Pediatrics (MD Paeds)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad-Haroon Hamid, MBBS,FCPS,FRCP

Role: PRINCIPAL_INVESTIGATOR

chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King edward medical university/mayo hospital lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22.

Reference Type BACKGROUND
PMID: 24429155 (View on PubMed)

Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.

Reference Type BACKGROUND
PMID: 25024668 (View on PubMed)

Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.

Reference Type BACKGROUND
PMID: 24429154 (View on PubMed)

Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.

Reference Type BACKGROUND
PMID: 25164315 (View on PubMed)

Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.

Reference Type BACKGROUND
PMID: 23290189 (View on PubMed)

Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.

Reference Type BACKGROUND
PMID: 25652104 (View on PubMed)

Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.

Reference Type BACKGROUND
PMID: 24345031 (View on PubMed)

Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.

Reference Type BACKGROUND
PMID: 27996280 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://pubmed.ncbi.nlm.nih.gov/24429155/

Powell C, Dona RK, Lowe, J, Boland A, Petrou S, Doull I, et al. Magnesium sulphate in acute sever asthma in children (MAGNETIC): a randomized, placebo-controlled trial. The Lancet Respiratory Medicine. 2013;1(4):301-8.

https://pubmed.ncbi.nlm.nih.gov/25024668

Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients.J Pediatr Pharmacol Ther. 2014;19(2) :91-7.

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

Goodacre S, Cohen J, Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial.Lancet Respir Med. 2013;1(4

http://pubmed.ncbi.nlm.nih.gov/25164315/

Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Peadiatrica. 2014;103(12):1301-6

http://pubmed.ncbi.nlm.nih.gov/23290189/

Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J,et al. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respiratory medicine. 2013;107(3):321-30.

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

Alansari K, Ahmed W, Davidson B, Alamri M, Zakaria I, Alrifaari M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized tria.Pediatr Pumonol 2015;50(12):1191-9.

http://pubmed.ncbi.nlm.nih.gov/24345031/

Albuali WH. The Use of Intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal.2014;27(17):1809-15.

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

aengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac/allergy immunol. 2016; 35(2):108-

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

137/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.