The Effect of Oral Intake on Pain Score in Children Undergoing Herniorrhaphy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- whether oral intake influences postoperative pain score in children
研究概览
简要总结
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score.
A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting.
The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery
排除标准
- •neurological disease, developmental delay
研究组 & 干预措施
2 hours after surgery
the investigators permit the patients to resume oral intake two hours after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability
干预措施: two hours (Other)
1 hour after surgery
the investigators permit the patients to resume oral intake one hour after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability
干预措施: one hour (Other)
结局指标
主要结局
whether oral intake influences postoperative pain score in children
时间窗: 90 minutes after surgery
pain degree is assessed using mCHEOPS and FLACC in young children, and using FPS-R in older (8 years or older) children
次要结局
- postoperative nausea and vomiting(4 hours on average)
研究者
Kazuhiko Okuyama, MD
Chief anesthesiologist
Ibaraki Children's Hospital