A Phase 4 interventional study of Nebulized Magnesium Sulfate and Nebulized isotonic saline in Asthma, sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval. Status unknown at 1 site in Mexico. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Phase 4, Interventional, and Treatment
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
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
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 152 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Hospital General Naval de Alta Especialidad - Escuela Medico Naval is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone
Drug: Nebulized Magnesium Sulfate · Drug: Nebulized Salbutamol · Drug: Ipratropium bromide · Drug: Methylprednisolone or Prednisolone
Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone
Drug: Nebulized isotonic saline · Drug: Nebulized Salbutamol · Drug: Ipratropium bromide · Drug: Methylprednisolone or Prednisolone
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.
Also known as: MgSO4
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.
Also known as: Standard treatment
Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
Nebulized ipratropium bromide 250 mcg
Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
Also known as: Corticosteroid therapy
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.
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Scalene muscle contraction
Absent (0) or Present (2)
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Suprasternal retractions
Absent (0) or Present (2)
Time frame: 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)
Time frame: 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
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline O2 saturation
≥95% (0), 92%-94% (1) or \<92% (2)
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Rate of hospitalization
Reduction the rate of hospitalization
Time frame: 4 hour
Change from Baseline Heart rate
Beats per minute
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Respiratory rate
Breaths per minute
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Blood pressure
mmHg
Time frame: 60 minutes after beginning treatment
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Hospital General Naval de Alta Especialidad - Escuela Medico Naval