Antipyretic Therapy With and Without Cold Sponging: A Comparative Study in Febrile Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Fever reduction
研究概览
简要总结
This study aims to fill the gaps regarding the effectiveness of paracetamol alone with paracetamol combined with cold sponging in febrile children.
详细描述
Given the conflicting findings in existing literature, the role of cold sponging in fever management remains uncertain. Some studies suggest a transient advantage in early temperature reduction, while others highlight limited long-term benefit and increased discomfort. Therefore, this study seeks to determine whether cold sponging offers meaningful additional benefit or merely adds distress without enhancing the efficacy of paracetamol. The findings would generate evidence-based guidance for using cold sponging in febrile children.
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
- None
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender
- •Aged 6 to 60 months.
- •Presenting with a fever (an axillary or oral temperature >38.0°C)
- •No use of paracetamol or other antipyretics within the past 6 hours.
- •Parental/guardian giving informed written consent.
排除标准
- •Children with chronic systematic conditions (e.g., congenital heart defects, renal or respiratory diseases)
- •History of febrile seizures or other seizure disorders
- •Known hypersensitivity or contraindication to paracetamol
- •Presence of dermatological conditions that may aggravate by sponging (eg., eczema, contact dermatitis, psoriasis, skin infection, xerosis)
研究组 & 干预措施
Paracetamol Group
Children will receive paracetamol alone, as a single dose of paracetamol syrup (15 mg/kg) orally.
干预措施: Paracetamol (Drug)
Cold sponging Group
Children will receive paracetamol as a single dose of paracetamol syrup (15 mg/kg) orally, and cold sponging will be performed immediately following paracetamol administration for 15 minutes, using room-temperature water (approximately 25°C) to sponge the forehead, arms, and legs.
干预措施: Paracetamol+Cold Sponging (Combination Product)
结局指标
主要结局
Fever reduction
时间窗: 60 minutes
Achievement of a temperature \<38°C within 60 minutes will be considered as the reduction in fever and effectiveness of the treatment.
次要结局
- Change in heart rate(60 minutes)
- Change in respiratory rate(60 minutes)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research