Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

NCT04929626 | Completed Phase 1

• 1 other identifier: Doses of Nebulized MgSO4
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Asthmaticus

Keywords

asthma; nebulized; magnesium sulphate

Outcome Measures

Primary Outcomes (6)

• Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline

  The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+).

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

• Change from baseline Suprasternal indrawing

  Absent (0) , Present (2)

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

• Change from baseline Scalene retractions

  Absent (0) , Present (2)

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

• Change from baseline Wheezing

  Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

• Change from baseline Air entry

  Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

• Change from baseline Oxygen saturation on room air

  \>93% (0), 90%-93% (1) or \<90% (2)

  20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment

Secondary Outcomes (2)

• Hospital stay

  24 hours

• Hospital stay

  48 hours

Study Arms (2)

Nebulized Ventolin

ACTIVE COMPARATOR

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

Drug: Ventolin

Nebulized Magnesium Sulphate + Ventolin

EXPERIMENTAL

Dose of Nebulized Magnesium sulphate will vary in 3 subgroups.

Drug: Magnesium Sulfate 500 mg/ml+ ventolin

Interventions

Magnesium Sulfate 500 mg/ml+ ventolin DRUG

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

Also known as: MgSO4

Nebulized Magnesium Sulphate + Ventolin

Ventolin DRUG

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

Also known as: Salbutamol

Nebulized Ventolin

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 2 to 12 years of age.
• Children with the diagnosis of asthma having a pram score of more than 4.
• Children with reactive airways

You may not qualify if:

• Critically ill children who require intubation or mechanical ventilation.
• Having hypersensitivity or allergy to MgSO4.
• with history of chronic lung impairment.
• Whose parents are not giving informed consent for participation in research.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Rabia Asif

Karachi, Sindh, 75530, Pakistan

Location

Related Publications (22)

• 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.

  PMID: 25652104 BACKGROUND

• Mustafa J, Iqbal SMJ, Azhar IA, Sultan MA. Nebulized magnesium sulphate as an adjunct therapy in the management of children presenting with acute exacerbation of asthma. Pakistan J Med Heal Sci. 2018;12(2):554-5.

  BACKGROUND

• 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.

  PMID: 27996280 BACKGROUND

• Turker S, Dogru M, Yildiz F, Yilmaz SB. The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):115-120. doi: 10.1016/j.aller.2016.10.003. Epub 2017 Jan 31.

  PMID: 28153353 BACKGROUND

• Sarhan HA, El-Garhy OH, Ali MA, Youssef NA. The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma. Drug Des Devel Ther. 2016 Jun 9;10:1927-33. doi: 10.2147/DDDT.S103147. eCollection 2016.

  PMID: 27354766 BACKGROUND

• Schuh S, Sweeney J, Freedman SB, Coates AL, Johnson DW, Thompson G, Gravel J, Ducharme FM, Zemek R, Plint AC, Beer D, Klassen T, Curtis S, Black K, Nicksy D, Willan AR; Pediatric Emergency Research Canada Group. Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. Trials. 2016 May 24;17(1):261. doi: 10.1186/s13063-015-1151-x.

  PMID: 27220675 BACKGROUND

• Kew KM, Kirtchuk L, Michell CI. Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department. Cochrane Database Syst Rev. 2014 May 28;2014(5):CD010909. doi: 10.1002/14651858.CD010909.pub2.

  PMID: 24865567 BACKGROUND

• Akter T, Islam N, Hoque MA, Khanam S, Saha BK. Original Article 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 . 2014;9(2):61-7.

  BACKGROUND

• 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.

  PMID: 24144222 BACKGROUND

• Hendaus MA, Jomha FA, Alhammadi AH. Is ketamine a lifesaving agent in childhood acute severe asthma? Ther Clin Risk Manag. 2016 Feb 22;12:273-9. doi: 10.2147/TCRM.S100389. eCollection 2016.

  PMID: 26955277 BACKGROUND

• Dexheimer JW, Abramo TJ, Arnold DH, Johnson KB, Shyr Y, Ye F, Fan KH, Patel N, Aronsky D. An asthma management system in a pediatric emergency department. Int J Med Inform. 2013 Apr;82(4):230-8. doi: 10.1016/j.ijmedinf.2012.11.006. Epub 2012 Dec 4.

  PMID: 23218449 BACKGROUND

• Kumar A. Effectiveness of Nebulized Magnesium Sulphate as an Adjuvant Therapy (With Salbutamol) in the Management of Acute Asthma. Pakistan J Med Dent. 2020;9(02):39-44.

  BACKGROUND

• Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, Haahtela T, Hurd SS, Inoue H, de Jongste JC, Lemanske RF Jr, Levy ML, O'Byrne PM, Paggiaro P, Pedersen SE, Pizzichini E, Soto-Quiroz M, Szefler SJ, Wong GW, FitzGerald JM. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015 Sep;46(3):622-39. doi: 10.1183/13993003.00853-2015. Epub 2015 Jul 23.

  PMID: 26206872 BACKGROUND

• Al-Shamrani A, Al-Harbi AS, Bagais K, Alenazi A, Alqwaiee M. Management of asthma exacerbation in the emergency departments. Int J Pediatr Adolesc Med. 2019 Jun;6(2):61-67. doi: 10.1016/j.ijpam.2019.02.001. Epub 2019 Mar 15. No abstract available.

  PMID: 31388549 BACKGROUND

• Rehder KJ. Adjunct Therapies for Refractory Status Asthmaticus in Children. Respir Care. 2017 Jun;62(6):849-865. doi: 10.4187/respcare.05174.

  PMID: 28546381 BACKGROUND

• Indinnimeo L, Chiappini E, Miraglia Del Giudice M; Italian Panel for the management of acute asthma attack in children Roberto Bernardini. Guideline on management of the acute asthma attack in children by Italian Society of Pediatrics. Ital J Pediatr. 2018 Apr 6;44(1):46. doi: 10.1186/s13052-018-0481-1.

  PMID: 29625590 BACKGROUND

• Schuh S, Macias C, Freedman SB, Plint AC, Zorc JJ, Bajaj L, Black KJ, Johnson DW, Boutis K. North American practice patterns of intravenous magnesium therapy in severe acute asthma in children. Acad Emerg Med. 2010 Nov;17(11):1189-96. doi: 10.1111/j.1553-2712.2010.00913.x.

  PMID: 21175517 BACKGROUND

• 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.

  PMID: 24429154 BACKGROUND

• Ibrahim Z, Modawi FS, Almehaid AM, Alshenaifi NA, Albahouth ZI. REVIEW OF THE RECENT UPDATES REGARDING ACUTE ASTHMA EXACERBATION MANAGEMENT IN CHILDREN : A SIMPLE LITERATURE REVIEW Corresponding author : 2019;06(01):850-5

  BACKGROUND

• Petrou S, Boland A, Khan K, Powell C, Kolamunnage-Dona R, Lowe J, Doull I, Hood K, Williamson P. Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children. Int J Technol Assess Health Care. 2014 Oct;30(4):354-60. doi: 10.1017/S0266462314000440. Epub 2014 Nov 14.

  PMID: 25394502 BACKGROUND

• Shein SL, Speicher RH, Filho JO, Gaston B, Rotta AT. Contemporary treatment of children with critical and near-fatal asthma. Rev Bras Ter Intensiva. 2016 Jun;28(2):167-78. doi: 10.5935/0103-507X.20160020.

  PMID: 27305039 BACKGROUND

• Asif R, Rais H, Bai P, Aziz R. Comparison of doses of Nebulized Magnesium sulphate as an adjuvant treatment with salbutamol in children with Status Asthmaticus. Pak J Med Sci. 2024 May-Jun;40(5):927-932. doi: 10.12669/pjms.40.5.7682.

  PMID: 38827880 DERIVED

Related Links

• North American practice patterns of intravenous magnesium therapy in severe acute asthma in children
• Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial
• A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma
• The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment
• The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma
• Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial
• Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department
• 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
• MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children
• Is ketamine a lifesaving agent in childhood acute severe asthma?
• An asthma management system in a pediatric emergency department
• Effectiveness of Nebulized Magnesium Sulphate as an Adjuvant Therapy (With Salbutamol) in the Management of Acute Asthma
• A summary of the new Global Initiative for Asthma (GINA) strategy: a roadmap to asthma control
• Management of asthma exacerbation in the emergency departments
• Adjunct Therapies for Refractory Status Asthmaticus in Children
• Guideline on management of the acute asthma attack in children by Italian Society of Pediatrics
• Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial
• Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children
• Contemporary treatment of children with critical and near-fatal asthma

MeSH Terms

Conditions

Status Asthmaticus; Asthma

Interventions

Magnesium Sulfate; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Rabia Asif, MBBS, PGT

  Ziauddin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The principal investigator was aware of the intervention being provided. Others were masked including the participant and care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 18, 2021
• Study Start: January 1, 2022
• Primary Completion: November 12, 2022
• Study Completion: November 12, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)