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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Ventolin | Active Comparator | Nebulized Ventolin will given to 1st group after every 20 min for 1 hour |
|
| Nebulized Magnesium Sulphate + Ventolin | Experimental | Dose of Nebulized Magnesium sulphate will vary in 3 subgroups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | curtailment in the length of hospital stay | 24 hours |
| Hospital stay | curtailment in the length of hospital stay | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabia Asif, MBBS, PGT | Ziauddin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabia Asif | Karachi | Sindh | 75530 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25652104 | Background | 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. | |
| 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. | ||
| 27996280 |
| Label | URL |
|---|---|
| North American practice patterns of intravenous magnesium therapy in severe acute asthma in children | View source |
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| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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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
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The principal investigator was aware of the intervention being provided. Others were masked including the participant and care provider.
|
| Ventolin | Drug | it will be given to control group in nebulized form after every 20 min in 1st hour |
|
|
| 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. |
| 28153353 | 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. |
| 27354766 | 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. |
| 27220675 | 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. |
| 24865567 | 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. |
| 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. |
| 24144222 | 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. |
| 26955277 | 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. |
| 23218449 | 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. |
| 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. |
| 26206872 | 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. |
| 31388549 | 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. |
| 28546381 | Background | Rehder KJ. Adjunct Therapies for Refractory Status Asthmaticus in Children. Respir Care. 2017 Jun;62(6):849-865. doi: 10.4187/respcare.05174. |
| 29625590 | 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. |
| 21175517 | 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. |
| 24429154 | 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. |
| 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 |
| 25394502 | 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. |
| 27305039 | 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. |
| 38827880 | Derived | 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. |
| Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial | View source |
| A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma | View source |
| The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment | View source |
| The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma | View source |
| Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial | View source |
| Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department | View source |
| 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 | View source |
| MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children | View source |
| Is ketamine a lifesaving agent in childhood acute severe asthma? | View source |
| An asthma management system in a pediatric emergency department | View source |
| A summary of the new Global Initiative for Asthma (GINA) strategy: a roadmap to asthma control | View source |
| Management of asthma exacerbation in the emergency departments | View source |
| Adjunct Therapies for Refractory Status Asthmaticus in Children | View source |
| Guideline on management of the acute asthma attack in children by Italian Society of Pediatrics | View source |
| Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial | View source |
| Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children | View source |
| Contemporary treatment of children with critical and near-fatal asthma | View source |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |