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临床试验/CTRI/2024/06/068571
CTRI/2024/06/068571已完成3 期

Intravenous Hydrocortisone versus Intravenous Dexamethasone in Children Hospitalized with Acute Severe Asthma:A Randomized Controlled Trial

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年6月16日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
140
试验地点
1
主要终点
Duration of stay in the emergency department

研究概览

简要总结

Corticosteroids play an important role in the management of Acute Severe Asthma and are the mainstay treatment of asthma. Published literature addressing the dose and type of steroids is very conflicting. Although the role of Intravenous corticosteroids in acute asthma is well established, this study aims to compare two Intravenous steroid preparations i.e. Hydrocortisone and Dexamethasone in the management of patients presenting with Acute Severe Asthma. Patients will be divided into two groups: Group I will receive Intravenous Dexamethasone 0.6 mg/kg single dose, max. dose of 16 mg/day and to be repeated after 24 hours if required and if a child can take it orally, to be given oral 0.6mg/kg single dose on Day 2 of admission and Group II will receive Intravenous Hydrocortisone (8 mg/kg) max dose of 100 mg followed by 4 mg/kg q8h on Day 1 and if child is accepting orally to be shifted on Oral Prednisolone 1 mg/kg/day for 4 days. And if the child is not accepting orally we will give Intravenous hydrocortisone 4 mg/kg/day divided 12h on Day 2 and 4 mg/kg single dose on Day 3.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children diagnosed with acute severe asthma consistent with severity as per Global Initiative for Asthma Guidelines and Pediatric Asthma Severity Score.

排除标准

  • Patients with cardiovascular, neurological, psychiatric, neoplastic, or renal disease.
  • Patients with respiratory conditions like pneumonia, pneumothorax, or pneumomediastinum will be excluded.
  • Those children whose parents refused to give consent to participate in the study.
  • Children who have received any systemic steroid preparations in the last 15 days before hospital arrival.

结局指标

主要结局

Duration of stay in the emergency department

时间窗: 6 hours to 48 hours

Length of stay in Hospital

时间窗: 6 hours to 48 hours

Need for PICU Transfer

时间窗: 6 hours to 48 hours

次要结局

  • Auscultatory findings(Frequency of betaagonist)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kapil Bhalla

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak Haryana

研究点 (1)

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