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Clinical Trials/NCT02584738
NCT02584738
Unknown
Phase 4

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

Hospital General Naval de Alta Especialidad - Escuela Medico Naval1 site in 1 country152 target enrollmentSeptember 2015

Overview

Phase
Phase 4
Intervention
Nebulized isotonic saline
Conditions
Asthma
Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Enrollment
152
Locations
1
Primary Endpoint
Change from Baseline Preschool Respiratory Assessment Measure (PRAM)
Last Updated
10 years ago

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

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
January 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Responsible Party
Sponsor

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
  • 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.

Arms & Interventions

Nebulized isotonic saline

Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Intervention: Nebulized isotonic saline

Nebulized Magnesium Sulfate

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone

Intervention: Methylprednisolone or Prednisolone

Nebulized Magnesium Sulfate

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone

Intervention: Nebulized Magnesium Sulfate

Nebulized Magnesium Sulfate

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone

Intervention: Nebulized Salbutamol

Nebulized Magnesium Sulfate

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone

Intervention: Ipratropium bromide

Nebulized isotonic saline

Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Intervention: Nebulized Salbutamol

Nebulized isotonic saline

Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Intervention: Ipratropium bromide

Nebulized isotonic saline

Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Intervention: Methylprednisolone or Prednisolone

Outcomes

Primary Outcomes

Change from Baseline Preschool Respiratory Assessment Measure (PRAM)

Time Frame: 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

Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Absent (0) or Present (2)

Change from Baseline Suprasternal retractions

Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Absent (0) or Present (2)

Change from Baseline Wheezing

Time Frame: 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

Time Frame: 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

Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

≥95% (0), 92%-94% (1) or \<92% (2)

Secondary Outcomes

  • Rate of hospitalization(4 hour)
  • Change from Baseline Heart rate(20, 40, 60, 120, 180 and 240 minutes after beginning treatment)
  • Change from Baseline Respiratory rate(20, 40, 60, 120, 180 and 240 minutes after beginning treatment)
  • Change from Baseline Blood pressure(60 minutes after beginning treatment)

Study Sites (1)

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