Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation
NCT ID: NCT02584738
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
152 participants
INTERVENTIONAL
2015-09-30
2018-01-31
Brief Summary
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Detailed Description
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Patients will be randomly assigned one of the two treatments in the Research: standard treatment for moderate to severe asthma attack, according to GINA or standard treatment plus nebulised magnesium sulphate, according to the table of random allocation of treatment.
Evaluations were performed after administration of each spray, that is, at 20, 40, 60, 120, 180 and 240 minutes after beginning treatment. The parameters' to evaluate are going to be heart rate, respiratory rate, oxygen saturation, blood pressure and assessment of severity of acute asthma with PRAM scale.
The application of nebulized drugs are made in the emergency department of pediatrics by inhalation therapy staff who are also responsible for the preparation of medicines. It is clear that this staff not participate in the evaluation of patients, which will be performed by the research staff or by medical staff on duty in the pediatric emergency department.
Patients and evaluating physician will not pick out between the two solutions for nebulization not only colour but also smell or other special feature, because the solutions were arranged in two identical syringes. Administered alone at the end of the study treatment is known.
Later the entry or exit of the patient decide, who can be egress to show clinical improvement with decreased severity index PRAM, patients will be graduates of an outpatient treatment according to international guidelines on the management of acute asthma. All initial and outcome data will be recorded in a format of data collection All decisions will be made by patients pediatricians emergency department which will follow patients throughout the study and will have the power to release the study patients to use other interventions that they consider clinically necessary
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nebulized Magnesium Sulfate
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4.
Intravenous methylprednisolone or oral prednisolone
Nebulized Magnesium Sulfate
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized Salbutamol
Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
Ipratropium bromide
Nebulized ipratropium bromide 250 mcg
Methylprednisolone or Prednisolone
Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
Nebulized isotonic saline
Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone
Nebulized isotonic saline
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized Salbutamol
Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
Ipratropium bromide
Nebulized ipratropium bromide 250 mcg
Methylprednisolone or Prednisolone
Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
Interventions
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Nebulized Magnesium Sulfate
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized isotonic saline
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized Salbutamol
Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
Ipratropium bromide
Nebulized ipratropium bromide 250 mcg
Methylprednisolone or Prednisolone
Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2 to 15 years old.
* Served in the pediatric emergency department of naval high specialty General Hospital from September to December 2015.
* Signing the consent by the parents.
Exclusion Criteria
* Severe kidney disease.
* Severe liver disease.
* Pregnancy.
* Known previous reaction to magnesium.
* Parents who have not signed the agreement.
* Patients without a clinical history of asthma.
* Clinical diagnosis of mild asthma attack.
* Previously included in the study.
* Presence of comorbidities that endanger the patient's life.
* The patient has clinical or gasometric criteria for advanced airway management.
* Life-threatening symptoms.
2 Years
15 Years
ALL
No
Sponsors
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Hospital General Naval de Alta Especialidad - Escuela Medico Naval
OTHER_GOV
Responsible Party
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Principal Investigators
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Jesús Abisai Uicab Saucedo, Pediatrician
Role: PRINCIPAL_INVESTIGATOR
Secretaria de Marina
Locations
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Hospital General Naval de Alta Especialidad
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Birken CS, Parkin PC, Macarthur C. Asthma severity scores for preschoolers displayed weaknesses in reliability, validity, and responsiveness. J Clin Epidemiol. 2004 Nov;57(11):1177-81. doi: 10.1016/j.jclinepi.2004.02.016.
Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.
Rodrigo GJ, Plaza Moral V, Forns SB, Castro-Rodriguez JA, de Diego Damia A, Cortes SL, Moreno CM, Nannini LJ, Neffen H, Salas J; SEPAR; ALAT. [ALERTA 2 guidelines. Latin America and Spain: recommendations for the prevention and treatment of asmatic exacerbations. Spanish Pulmonology and Thoracic Surgery Society (SEPAR). Asthma Department of the Latinamerican Thoracic Association (ALAT)]. Arch Bronconeumol. 2010 Oct;46 Suppl 7:2-20. doi: 10.1016/S0300-2896(10)70041-7. No abstract available. Spanish.
Gourgoulianis KI, Chatziparasidis G, Chatziefthimiou A, Molyvdas PA. Magnesium as a relaxing factor of airway smooth muscles. J Aerosol Med. 2001 Fall;14(3):301-7. doi: 10.1089/089426801316970259.
Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
Cairns CB, Kraft M. Magnesium attenuates the neutrophil respiratory burst in adult asthmatic patients. Acad Emerg Med. 1996 Dec;3(12):1093-7. doi: 10.1111/j.1553-2712.1996.tb03366.x.
Mohammed S, Goodacre S. Intravenous and nebulised magnesium sulphate for acute asthma: systematic review and meta-analysis. Emerg Med J. 2007 Dec;24(12):823-30. doi: 10.1136/emj.2007.052050.
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.
Powell C, Dwan K, Milan SJ, Beasley R, Hughes R, Knopp-Sihota JA, Rowe BH. Inhaled magnesium sulfate in the treatment of acute asthma. Cochrane Database Syst Rev. 2012 Dec 12;12:CD003898. doi: 10.1002/14651858.CD003898.pub5.
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.
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.
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.
Rowe BH. Intravenous and inhaled MgSO4 for acute asthma. Lancet Respir Med. 2013 Jun;1(4):276-7. doi: 10.1016/S2213-2600(13)70097-3. Epub 2013 May 17. No abstract available.
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.
Wang H, Xiong Y, Gong C, Yin L, Yan L, Yuan X, Liu S, Shi T, Dai J. Effect of inhaled magnesium sulfate on bronchial hyperresponsiveness. Indian J Pediatr. 2015 Apr;82(4):321-7. doi: 10.1007/s12098-014-1476-6. Epub 2014 Jun 12.
Smith SR, Baty JD, Hodge D 3rd. Validation of the pulmonary score: an asthma severity score for children. Acad Emerg Med. 2002 Feb;9(2):99-104. doi: 10.1111/j.1553-2712.2002.tb00223.x.
Chalut DS, Ducharme FM, Davis GM. The Preschool Respiratory Assessment Measure (PRAM): a responsive index of acute asthma severity. J Pediatr. 2000 Dec;137(6):762-8. doi: 10.1067/mpd.2000.110121.
Related Links
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Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (Updated 2015).
Other Identifiers
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HGNAE-03
Identifier Type: -
Identifier Source: org_study_id