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临床试验/NCT06959407
NCT06959407已完成不适用

Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup

Arooj Khan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Settlement of symptoms of Croup

研究概览

简要总结

Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Emergency treatments include cool mist, nebulized epinephrine, and steroids. Steroid therapy, particularly dexamethasone (oral or intramuscular), is commonly used, with recent studies suggesting intramuscular dexamethasone may be more effective. However, most research has focused on hospitalized patients, and there is a lack of local data for mild cases. This study aims to address that gap and improve patient counseling and future research

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
Single (Participant)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patient age 2 to 12 years
  • •Both genders
  • •Diagnosed with croup as operational definitions

排除标准

  • •Patients with chronic pulmonary disease like tuberculosis,
  • •Allergy or contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past three weeks), to corticosteroids,
  • •history of corticosteroid administration during the last four weeks,
  • •foreign body
  • •patients with immunodeficiency disorder

研究组 & 干预措施

Group A (oral dexamethasone )

Active Comparator

Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose

干预措施: oral dexamethasone (Drug)

Group B (intramuscular dexamethasone )

Active Comparator

Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose

干预措施: intramuscular dexamethasone (Drug)

结局指标

主要结局

Settlement of symptoms of Croup

时间窗: within 24 hours

complete or partial settlement of symptoms i.e barking cough, inspiratory stridor, difficulty in breathing and hoarseness of voice.

次要结局

未报告次要终点

研究者

发起方
Arooj Khan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arooj Khan

Post Graduate Resident, Department of Child Health

Khyber Teaching Hospital

研究点 (1)

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