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

November 30, 2015 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jesús Abisai Uicab Saucedo, Pediatrician
  • Phone Number: 5423 (52)5550371200
  • Email: abisaipec@msn.com

Study Locations

  • Mexico
    • Distrito Federal
      • México, Distrito Federal, Mexico, 04480
        • Recruiting
        • Hospital General Naval de Alta Especialidad
        • Contact:
          • Jesús Abisai Uicab Saucedo, Pediatrician
          • Phone Number: 5423 (52)5550371200
          • Email: abisaipec@msn.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized Magnesium Sulfate

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4.

Intravenous methylprednisolone or oral prednisolone
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.

Other Names:
  • MgSO4
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
Other Names:
  • Corticosteroid therapy
Placebo Comparator: Nebulized isotonic saline
Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone
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
Other Names:
  • Corticosteroid therapy
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.

Other Names:
  • Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Scalene muscle contraction
Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Absent (0) or Present (2)
20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Suprasternal retractions
Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Absent (0) or Present (2)
20, 40, 60, 120, 180 and 240 minutes after beginning treatment
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)
20, 40, 60, 120, 180 and 240 minutes after beginning treatment
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
20, 40, 60, 120, 180 and 240 minutes after beginning treatment
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)
20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

  • Principal Investigator: Jesús Abisai Uicab Saucedo, Pediatrician, Secretaria de Marina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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