A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The Reduction of Temperature
研究概览
简要总结
The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections.
This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
- •Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study
排除标准
- •History of hypersensitivity to any drugs or excipients of the study
- •Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
- •Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
- •Neurological and hemodynamics disorders
- •Evidence of liver or kidney impairment or heart failure
- •Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Diclofenac potassium
干预措施: Diclofenac potassium (Drug)
Acetaminophen
干预措施: Acetaminophen (Drug)
结局指标
主要结局
The Reduction of Temperature
时间窗: 2 hours
次要结局
- The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever(2 hours)
- Time to Reach a Reduction of Temperature as 0.5 and 1 °C(2 hours)
- Safety of Diclofenac Potassium Therapy in the Study Period(6 hours)
- Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours(6 hours)