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

Phase 4

• Conditions: Asthma
• Interventions: Drug: Nebulized isotonic saline; Drug: Nebulized Magnesium Sulfate; Drug: Nebulized Salbutamol; Drug: Ipratropium bromide; Drug: Methylprednisolone or Prednisolone

• Registration Number: NCT02584738
• Lead Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Brief 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

Detailed 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

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-23
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized Magnesium Sulfate	Nebulized Salbutamol	Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone
Nebulized Magnesium Sulfate	Methylprednisolone or Prednisolone	Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone
Nebulized isotonic saline	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	Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone
Nebulized isotonic saline	Methylprednisolone or Prednisolone	Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone
Nebulized Magnesium Sulfate	Nebulized Magnesium Sulfate	Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone
Nebulized Magnesium Sulfate	Ipratropium bromide	Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone
Nebulized isotonic saline	Ipratropium bromide	Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Primary Outcome Measures

Name	Time	Method
Change from Baseline Preschool Respiratory Assessment Measure (PRAM)	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Scalene muscle contraction, Suprasternal retractions, Wheezing, Air entry and O2 saturation.; The score will be considering from the addition per each primary measure.
Change from Baseline Scalene muscle contraction	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Absent (0) or Present (2)
Change from Baseline Suprasternal retractions	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Absent (0) or Present (2)
Change from Baseline Wheezing	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Normal (0), Decreased at bases (1), Widespread decrease (2), or Absent/minimal (3)
Change from Baseline Air entry	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Absent (0), Expiratory only (1), Inspiratory and expiratory (2) or Audible without (3) stethoscope/silent chest with minimal air entry
Change from Baseline O2 saturation	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	≥95% (0), 92%-94% (1) or \<92% (2)

Secondary Outcome Measures

Name	Time	Method
Rate of hospitalization	4 hour	Reduction the rate of hospitalization
Change from Baseline Heart rate	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Beats per minute
Change from Baseline Respiratory rate	20, 40, 60, 120, 180 and 240 minutes after beginning treatment	Breaths per minute
Change from Baseline Blood pressure	60 minutes after beginning treatment	mmHg

Trial Locations

Locations (1)

Hospital General Naval de Alta Especialidad; 🇲🇽 México, Distrito Federal, Mexico