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

Study Overview
=================
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

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Nebulized Magnesium Sulfate
* Drug: Nebulized isotonic saline
* Drug: Nebulized Salbutamol
* Drug: Ipratropium bromide
* Drug: Methylprednisolone or Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Magnesium Sulfate<br>Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone | Drug: Nebulized Magnesium Sulfate<br>* 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.<br>* Other names: MgSO4;Drug: Nebulized Salbutamol<br>* Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)<br>Drug: Ipratropium bromide<br>* Nebulized ipratropium bromide 250 mcg<br>Drug: Methylprednisolone or Prednisolone<br>* Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment<br>* Other names: Corticosteroid therapy;|
| Placebo Comparator: Nebulized isotonic saline<br>Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone | Drug: Nebulized isotonic saline<br>* 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.<br>* Other names: Standard treatment;Drug: Nebulized Salbutamol<br>* Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)<br>Drug: Ipratropium bromide<br>* Nebulized ipratropium bromide 250 mcg<br>Drug: Methylprednisolone or Prednisolone<br>* Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment<br>* Other names: Corticosteroid therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from Baseline Scalene muscle contraction | Absent (0) or Present (2) | 20, 40, 60, 120, 180 and 240 minutes after beginning treatment | 
| Change from Baseline Suprasternal retractions | Absent (0) or Present (2) | 20, 40, 60, 120, 180 and 240 minutes after beginning treatment | 
| 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 | 
| 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 | 
| Change from Baseline O2 saturation | ≥95% (0), 92%-94% (1) or <92% (2) | 20, 40, 60, 120, 180 and 240 minutes after beginning treatment | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Exacerbation, Nebulization, Magnesium, Pediatric