Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Duration of feeding and/or drinking difficulties
研究概览
简要总结
Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Valacyclovir
Valacyclovir will be given twice a day with following doses according to weight:
10 to 13,9 kg : Valacyclovir 250 mg PO twice per day 14 to 19,9 kg : Valacyclovir 375 mg PO twice per day 20 to 28 kg : Valacyclovir 500 mg PO twice per day
干预措施: Valacyclovir (Drug)
control
placebo pill
干预措施: placebo (Drug)
结局指标
主要结局
Duration of feeding and/or drinking difficulties
时间窗: 2 weeks
This will be defined by the number of days until the participants return to normal feeding and eating according to the parents.
次要结局
- adverse side effects(2 weks)
- duration of fever(2 weeks)
- global parent satisfaction(2 weeks)
- duration of pain(2 weeks)
- duration of oral lesions(2 weeks)
- duration of school or work absence(2 weeks)
- utilisation of medical resources(2 weeks)
研究者
Jocelyn Gravel
MD, MSc, FRCPC
St. Justine's Hospital