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临床试验/NCT01739985
NCT01739985已完成不适用

Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2010年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
322
试验地点
1
主要终点
Postoperative vomiting

研究概览

简要总结

The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.

详细描述

The overall incidence of postoperative vomiting between 25 and 30% for the pediatric population, but it can reach a much higher incidence associated with certain types of surgery, about 80% in some studies like strabismus surgery for example. The identification of patients at high risk of POV is possible through the use of risk score. It is currently only one pediatric validated risk score, but the investigators conducted a multicenter study on this subject, whose results are being analyzed. This should allow us to identify children at high risk of POV. In this targeted population, the prophylaxis should allow a significant reduction in the incidence of POV. In children only one study tried to evaluate the association of ondansetron, dexamethasone and droperidol to prevent postoperative vomiting. However, different doses of the different molecules were combined, the extremely complicated design of this study and important methodological bias do not provide evidence about the superiority of the combination of three anti-emetics compared with two anti-emetics. Our present randomized, double-blind study is designed to compare the effectiveness of Droperidol in combination with a conventional bi-prophylaxis (dexamethasone/ondansetron) to the conventional bi-prophylaxis alone to decrease the occurrence of postoperative vomiting in children at high risk. The combination ondansetron and dexamethasone is frequently assessed as an association to prevent postoperative vomiting also in the adult population and in the pediatric population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
  • Between 3 to 18 years
  • Informed consent signed or the owner (s) of parental
  • Children receiving a social security system

排除标准

  • Ambulatory surgery
  • Preoperative corticosteroids
  • Postoperative sedation
  • Allergy known to droperidol, ondansetron or dexamethasone
  • Known hypokaliemia
  • Known hypomagnesemia
  • Bradycardia (<55 bpm)
  • Congenital long QT syndrome
  • Treatment that induce prolonged QT
  • Pheochromocytoma
  • Severe depressive syndrome

研究组 & 干预措施

Dexamethasone + ondansetron + Placebo

Active Comparator

dexamethasone + ondansetron + Placebo

干预措施: Dexamethasone + ondansetron + Placebo (Drug)

Dexamethasone + ondansetron + Droperidol

Experimental

dexamethasone + ondansetron + Droperidol

干预措施: Dexamethasone + ondansetron + Droperidol (Drug)

结局指标

主要结局

Postoperative vomiting

时间窗: 24 hours

次要结局

  • Safety and Tolerability(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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