Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 808
- 试验地点
- 1
- 主要终点
- Time between withdrawal of orotracheal tube and POV
研究概览
简要总结
At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.
Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.
The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).
The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of less than 4 years old
- •A pediatric day case surgery scheduled
排除标准
- •Child lower age or 3 month old equal
- •Premature child of conceptional age lower than 60 weeks
- •Anesthetic or surgical constraint dissuading day case surgery or early refeeding
- •Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)
- •treatment interfering with emesis (imidazoles, neuroleptic)
- •Period of exclusion defined by another study
结局指标
主要结局
Time between withdrawal of orotracheal tube and POV
时间窗: The participant are followed for 3 days.
次要结局
未报告次要终点