Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of hospital admissions
研究概览
简要总结
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. There is still no consensus on the medical management of the disease, in clinical practice there is wide variability in the treatment with inhaled drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of the disease, which results in increased morbidity and a major economic benefit for all health services.
Several studies are in relation to the management of bronchiolitis, one of which was made during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing 3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was demonstrated, it was not possible to establish difference statistically significant between them. Why it was considered necessary to continue the study focused on determining the difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this investigation is to determine whether there is a difference between the use of dexamethasone and epinephrine versus hypertonic saline (3%).
详细描述
Respiratory tract infections are one of the leading causes of consultation in the Hospital General Naval de Alta Especialidad, in the emergency department and outpatient. Only in the last year (2014) shows that a total of 2690 pediatric consultations were provided in the emergency department, 1000 of them were for respiratory tract infections, constituting an approximate percentage of 37%. This figure increased over the previous year (2013) in which emergency visits corresponding 1130 290 cases consultations with boxes airways getting a percentage of 25% is given.
Due to the high incidence of lower respiratory tract infections among patients in the pediatric ward, specifically for infants under two patients; early diagnosis of acute bronchiolitis is essential to initiate proper management without falling into the overuse of drugs that have not shown adequate results.
In the last five years it has seen an increase in cases of bronchiolitis treated in both outpatient or emergency department of the Naval General Hospital. Given these data, a priority for a reason and consensus of treatment for patients with bronchiolitis.
Faced with these alarming epidemiological data both nationally and globally, it is difficult to understand that there is no consensus on the management of this entity. Although mortality is low, it represents a high cost for society and especially for health institutions, represented by a high rate of income, empirical treatments and other logistical issues.
This document intends to obtain evidence of better treatment in the population in order to establish an optimal management without spilling resources would reduce the rate of hospital admissions, first to the Naval General Hospital of High Specialty and then unify all Naval Health centers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 2 years of age diagnosed with bronchiolitis
- •Be beneficiaries Marine
- •Outpatient
- •Severity of Bronchiolitis mild to moderate scale according to Difficulty rating scale Respiratory (RDAI) for bronchiolitis (RDAI score 2-8).
排除标准
- •Patients with a history of atopy
- •Patients with a history of asthma in infants.
- •Patients with comorbidity
- •RDAI> 9 at diagnosis.
研究组 & 干预措施
HS3% group
Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.
干预措施: Epinephrine and Dexamethasone (Drug)
ED group
Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml.
干预措施: Hypertonic Saline 3% (Drug)
结局指标
主要结局
Rate of hospital admissions
时间窗: 7 days after treatment
Tracking each patient until 7 days after treatment to verify hospitalization rate.
次要结局
- Respiration after treatment in the First Day.(20 minutes after administration of treatment.)
- Heart rate after treatment in the First Day.(20 minutes after administration of treatment.)
- Diastolic and Systolic blood pressure after treatment in the First Day.(20 minutes after administration of treatment.)
- Oxygen Saturation After after treatment in the First Day.(20 minutes after administration of treatment.)