A randomised controlled trial comparing high-dose paracetamol and oral ibuprofen for fever management in children
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 1. time taken to reduce fever by either of the drug
研究概览
简要总结
This study is a double-blinded randomized controlled trial designed to compare the efficacy and safety of high-dose paracetamol versus oral ibuprofen in managing fever among children aged 6 to 18 years. Conducted over 24 months at Ruby Hall Clinic, it will enroll 69 participants and evaluate how quickly each drug reduces fever and associated discomfort, along with any immediate adverse effects. Temperature will be monitored every 30 minutes, and pain scores assessed using age-appropriate tools.Children meeting inclusion criteria will receive weight-based doses of either drug every 6 hours, with both caregivers and nurses blinded to the treatment groups. The study excludes children with prior drug use, allergies, or severe illness. Ethical approval and informed consent are mandatory, with no use of placebo or off-label drugs, and no additional cost to participants. The central hypothesis is that high-dose paracetamol may be more effective than ibuprofen in reducing fever in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with fever (axillary temperature of more than 100 F) admitted to pediatric ward in Ruby Hall Clinic and willing to participate in study.
排除标准
- •1.Those patients who have received either of the drug in previous 6 hours.
- •2.Received antibiotics prior to admission.
- •3.Those receiving anti-coagulants warfarin, heparin etc.
- •4.Those patients having localized inflammatory pain.
- •5.Known case of asthma.
- •6.Known case of allergy to either drug.
- •7.Chronic cardiac or hepatic or renal failure requiring ICU care.
- •8.Any clinical adverse event or serious illness.
- •9.Those patients not willing to participate in study.
结局指标
主要结局
1. time taken to reduce fever by either of the drug
时间窗: AT BASELINE, 4 DAYS AND 8 DAYS
2. The decrease in fever associated discomfort following administration of either drug.
时间窗: AT BASELINE, 4 DAYS AND 8 DAYS
次要结局
- To determine any immediate adverse effects following drug administration.(24 hours)
研究者
DR KANCHANKUMAR BHAGYAWANT
RUBY HALL CLINIC