Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 3
- 主要终点
- Proportion of subjects with abnormal serum transaminase levels on the last day of fever
研究概览
简要总结
The purpose of this study is to determine whether regular dosage of paracetamol causes transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age >18 years
- •Dengue infection diagnosed by NS1 antigen, Dengue immunoglobulin M antibody, or polymerase chain reaction
- •Admitted to the hospital
- •Written informed consent from patient or attending relative able to and willing to give informed consent
排除标准
- •Other possible cause of fever other than dengue infection
- •Pregnancy
- •Unable to take medication
- •Aminotransferase level above 3 times upper normal limit
- •Allergy to paracetamol or tramadol
- •Paracetamol indicated for condition other than dengue infection
- •Critically ill patient who need ICU or invasive ventilation support
- •History of cirrhosis
- •Unable to comunicate
研究组 & 干预措施
Paracetamol
Eligible patients will be randomised to receive Paracetamol prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
干预措施: Paracetamol (Drug)
Placebo
Eligible patients will be randomised to receive Placebo prn for fever at maximum dosage of 500 mg PO q 4 hr (3 gm/day)
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with abnormal serum transaminase levels on the last day of fever
时间窗: Day 1-8
Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared.
Mean serum transaminase level
时间窗: Day 1-8
Mean serum transaminase level will be compared.
Mean change in serum transaminase levels
时间窗: Day 1-8
The change in serum transaminase levels from baseline at admission will be compared.
次要结局
- Number of drug tablet used(8 days)
- Body temperature(8 days)
- Length of stay(10 days)
- Duration of fever(8 days)