Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

Status Asthmaticus Clinical Trial

Official title:

Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929626
• Other study ID #: Doses of Nebulized MgSO4
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2022
• Est. completion date: November 12, 2022

Study information

• Verified date: April 2023
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

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

Locations

Country	Name	City	State
Pakistan	Rabia Asif	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

References & Publications (21)

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.

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. Erratum In: Int J Pediatr Adolesc Med. 2020 Dec;7(4):212. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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;(5):CD010909. doi: 10.1002/14651858.CD010909.pub2. — View Citation

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.

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline Suprasternal indrawing	Absent (0) , Present (2)	20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Primary	Change from baseline Scalene retractions	Absent (0) , Present (2)	20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Primary	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
Primary	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
Primary	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	Hospital stay	curtailment in the length of hospital stay	24 hours
Secondary	Hospital stay	curtailment in the length of hospital stay	48 hours

External Links

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