跳至主要内容
临床试验/NCT01725399
NCT01725399已完成不适用

Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
2
主要终点
Post-operative Vomiting

研究概览

简要总结

Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Dental surgery
  • Tonsillectomy and adenoidectomy
  • Strabismus surgery

排除标准

  • Patient refusal
  • Parent refusal
  • Allergy / contraindication to ondansetron
  • Prone to vomiting
  • Inpatient
  • Preoperative anxiolysis with ketamine
  • Recovery location other than PACU
  • Nil per os at baseline
  • Presence of enteric tube
  • Contraindication to any part of the study protocol

结局指标

主要结局

Post-operative Vomiting

时间窗: 24 hr post-op

Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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