NCT02584738

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Other Government
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma

Interventions

Type	Name	Description
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.
DRUG	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.
DRUG	Nebulized Salbutamol	Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
DRUG	Ipratropium bromide	Nebulized ipratropium bromide 250 mcg
DRUG	Methylprednisolone or Prednisolone	Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2018-01-01
• First posted: 2015-10-23
• Last updated: 2015-12-02

Locations

1 site across 1 country: Mexico