Clinical trial NCT02584738: Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation
Official title: Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Exacerbation
Nebulization
Magnesium
Pediatric
Lead sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor class: OTHER_GOV
First posted: 2015-10-23
Enrollment: 152
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Change from Baseline Preschool Respiratory Assessment Measure (PRAM)
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Scalene muscle contraction
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Suprasternal retractions
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Wheezing
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Air entry
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline O2 saturation
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Secondary outcomes:
measure: Rate of hospitalization
timeFrame: 4 hour
measure: Change from Baseline Heart rate
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Respiratory rate
timeFrame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
measure: Change from Baseline Blood pressure
timeFrame: 60 minutes after beginning treatment
Other outcomes:
Locations:
city: México
country: Mexico
facility: Hospital General Naval de Alta Especialidad
state: Distrito Federal
Study officials:
affiliation: Secretaria de Marina
name: Jesús Abisai Uicab Saucedo, Pediatrician
role: PRINCIPAL_INVESTIGATOR
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