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临床试验/NCT02584738
NCT02584738Unknown4 期

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 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
152
试验地点
1
主要终点
Change from Baseline Preschool Respiratory Assessment Measure (PRAM)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Nebulized isotonic saline

Placebo Comparator

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

干预措施: Nebulized isotonic saline (Drug)

Nebulized Magnesium Sulfate

Experimental

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

Intravenous methylprednisolone or oral prednisolone

干预措施: Methylprednisolone or Prednisolone (Drug)

Nebulized Magnesium Sulfate

Experimental

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

Intravenous methylprednisolone or oral prednisolone

干预措施: Nebulized Magnesium Sulfate (Drug)

Nebulized Magnesium Sulfate

Experimental

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

Intravenous methylprednisolone or oral prednisolone

干预措施: Nebulized Salbutamol (Drug)

Nebulized Magnesium Sulfate

Experimental

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

Intravenous methylprednisolone or oral prednisolone

干预措施: Ipratropium bromide (Drug)

Nebulized isotonic saline

Placebo Comparator

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

干预措施: Nebulized Salbutamol (Drug)

Nebulized isotonic saline

Placebo Comparator

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

干预措施: Ipratropium bromide (Drug)

Nebulized isotonic saline

Placebo Comparator

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

干预措施: Methylprednisolone or Prednisolone (Drug)

结局指标

主要结局

Change from Baseline Preschool Respiratory Assessment Measure (PRAM)

时间窗: 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

时间窗: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Absent (0) or Present (2)

Change from Baseline Suprasternal retractions

时间窗: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Absent (0) or Present (2)

Change from Baseline Wheezing

时间窗: 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

时间窗: 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

时间窗: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment

≥95% (0), 92%-94% (1) or \<92% (2)

次要结局

  • 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)

研究者

发起方
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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