Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximal change in temperature during the 4-hour period after enrollment.
研究概览
简要总结
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.
Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.
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
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3 mo- 4 years
- •Weight 6 - 18 kg
- •Rectal temperature > 38.50
排除标准
- •Treatment with acetaminophen in the last 4 hours
- •Treatment with Ibuprofen in the last 6 hours
- •Unable to take oral or rectal medications
- •Hypersensitivity to ibuprofen
- •Renal failure
- •Liver disease
- •Rectal temperature can't be measured (due to anatomical or medical problem)
- •Informed consent could not be granted
研究组 & 干预措施
1
Ibuprofen Suppository
干预措施: Ibuprofen suppository (Drug)
2
Ibuprofen suspension
干预措施: Ibuprofen Suspension (Drug)
结局指标
主要结局
Maximal change in temperature during the 4-hour period after enrollment.
时间窗: 4 hours
次要结局
- Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.(4 h)