NCT00231478已完成4 期
A Randomized, Double-blind Study of 2 Dose Levels of Kytril on the Prevention of Post-operative Nausea and Vomiting in Pediatric Patients Undergoing Surgery With General Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 171
- 主要终点
- Number of Patients With no Vomiting
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months, and the planned sample size was 170 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females 2-16 years of age
- •scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy requiring general anesthesia and endotracheal intubation
- •scheduled for hospital admission for no longer than 24 hours
排除标准
- •known allergy or other contraindication to the use of Kytril or any of its components
- •known allergy to any other 5HT3 antagonist
- •history of motion sickness or post-operative nausea or vomiting
- •nausea or vomiting in the 24 hours prior to anesthesia
研究组 & 干预措施
1
Experimental
干预措施: granisetron (Drug)
2
Experimental
干预措施: granisetron (Drug)
结局指标
主要结局
Number of Patients With no Vomiting
时间窗: 0-2h after end of surgery (time of extubation)
Number of patients with no vomiting is described as no emesis up to 2 hours after surgery
次要结局
- Number of Patients With no Vomiting(0-24h after time of extubation)
- Time to First Vomiting Episode(0-24h after time of extubation)
- Adverse Experiences(infusion to 15 days post treatment)
研究者
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