Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Antipyretic efficacy
研究概览
简要总结
The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.
For the efficacy asses were compared:
- the time to start the action;
- the action duration;
- the difference between the basal temperature and the lower temperature in the study period.
For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.
排除标准
- •patients with a bad general heath state
- •patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;
- •intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;
- •moderated or severe dehydration;
- •conscience state alteration;
- •not capable of ingest oral drugs;
- •patients being treated with steroids;
- •patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.
研究组 & 干预措施
Acetaminophen
10 milligram per kilo, oral administration
干预措施: ibuprofen, dipyrone, acetaminophen (Drug)
Dipyrone
10 milligram per kilo, oral administration
干预措施: ibuprofen, dipyrone, acetaminophen (Drug)
Ibuprofen
10 milligram per kilo, oral administration
干预措施: ibuprofen, dipyrone, acetaminophen (Drug)
结局指标
主要结局
Antipyretic efficacy
时间窗: Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
The antipyretic efficacy was assessed comparing the time to the beggining of the action of the drugs, the difference between the final and inicial temperature and time of action.
次要结局
- Adverse Events(Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.)