Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation

Asthma Clinical Trial

Official title:

Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02584738
• Other study ID #: HGNAE-03
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2015
• Last updated: November 30, 2015
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: October 2015
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Jesús Abisai Uicab Saucedo, Pediatrician
• Phone: (52)5550371200
• Email: abisaipec[@]msn.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate in patient with moderate to severe asthma exacerbation in pediatric emergency

Description:

The inclusion period of the patients in this research will be on September 2015 to November 2015. Patients are going to be selected by the medical staff on duty in the emergency paediatric service, according to the criteria previously established inclusion and exclusion. Immediately a baseline degree of respiratory distress using PRAM scale and heart rate, respiratory rate, blood pressure and oxygen saturation. While informed consent in which the objective and characteristics of the study will be obtained will be explained.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: January 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of moderate or severe asthma exacerbations

• 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:

• Coexistence of lung disease.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Mexico	Hospital General Naval de Alta Especialidad	México	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Country where clinical trial is conducted

Mexico, 

References & Publications (17)

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

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. Review. — View Citation

Cairns CB, Kraft M. Magnesium attenuates the neutrophil respiratory burst in adult asthmatic patients. Acad Emerg Med. 1996 Dec;3(12):1093-7. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 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. Review. — 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

Rodrigo GJ, Plaza Moral V, Forns SB, Castro-Rodríguez JA, de Diego Damiá A, Cortés 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. Spanish. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Preschool Respiratory Assessment Measure (PRAM)	Scalene muscle contraction, Suprasternal retractions, Wheezing, Air entry and O2 saturation.; The score will be considering from the addition per each primary measure.	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Primary	Change from Baseline Scalene muscle contraction	Absent (0) or Present (2)	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Primary	Change from Baseline Suprasternal retractions	Absent (0) or Present (2)	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Primary	Change from Baseline Wheezing	Normal (0), Decreased at bases (1), Widespread decrease (2), or Absent/minimal (3)	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Primary	Change from Baseline Air entry	Absent (0), Expiratory only (1), Inspiratory and expiratory (2) or Audible without (3) stethoscope/silent chest with minimal air entry	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Primary	Change from Baseline O2 saturation	=95% (0), 92%-94% (1) or <92% (2)	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Secondary	Rate of hospitalization	Reduction the rate of hospitalization	4 hour	No
Secondary	Change from Baseline Heart rate	Beats per minute	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Secondary	Change from Baseline Respiratory rate	Breaths per minute	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	No
Secondary	Change from Baseline Blood pressure	mmHg	60 minutes after beginning treatment	No

External Links

•   Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (Updated 2015).