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

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ClinicalTrials.gov Identifier: NCT02584738
Recruitment Status : Unknown
Verified October 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Recruiting
First Posted : October 23, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Nebulized Magnesium Sulfate Drug: Nebulized isotonic saline Drug: Nebulized Salbutamol Drug: Ipratropium bromide Drug: Methylprednisolone or Prednisolone Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: 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 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 Name: Standard treatment

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 Name: Corticosteroid therapy




Primary Outcome Measures :
  1. 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.


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

  3. Change from Baseline Suprasternal retractions [ Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment ]
    Absent (0) or Present (2)

  4. 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)

  5. 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

  6. 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 Outcome Measures :
  1. Rate of hospitalization [ Time Frame: 4 hour ]
    Reduction the rate of hospitalization

  2. Change from Baseline Heart rate [ Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment ]
    Beats per minute

  3. Change from Baseline Respiratory rate [ Time Frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment ]
    Breaths per minute

  4. Change from Baseline Blood pressure [ Time Frame: 60 minutes after beginning treatment ]
    mmHg



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584738


Contacts
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Contact: Jesús Abisai Uicab Saucedo, Pediatrician (52)5550371200 ext 5423 abisaipec@msn.com

Locations
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Mexico
Hospital General Naval de Alta Especialidad Recruiting
México, Distrito Federal, Mexico, 04480
Contact: Jesús Abisai Uicab Saucedo, Pediatrician    (52)5550371200 ext 5423    abisaipec@msn.com   
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
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Principal Investigator: Jesús Abisai Uicab Saucedo, Pediatrician Secretaria de Marina

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02584738     History of Changes
Other Study ID Numbers: HGNAE-03
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: October 2015

Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
Asthma
Exacerbation
Nebulization
Magnesium
Pediatric

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Albuterol
Magnesium Sulfate
Ipratropium
Bromides
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents