NCT01477242Unknown不适用
The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- vomiting at ED stay and 12 hours after discharge
研究概览
简要总结
The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.
详细描述
Methods
- a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
- survey for the occurrence of vomiting at ED and after discharge
Primary outcome
- the number of vomiting at ED and at home
Secondary outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children under 18 years of age
- •children who are planned to admit ketamine intramuscular injection
- •children with ASA classification class I or II
排除标准
- •don't want to enroll to study
- •children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
- •children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
- •children under 3 months of age
- •children whose weight are over 30 kg
- •children managed by other drug with ketamine
研究组 & 干预措施
Ondansetron
Experimental
Ondansetron use group
干预措施: Ondansetron (Drug)
Placebo
Placebo Comparator
Placebo group
干预措施: Ondansetron (Drug)
结局指标
主要结局
vomiting at ED stay and 12 hours after discharge
时间窗: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
次要结局
- parent's satisfaction(satisfaction will be surveyed within 48hours after discharge)
- length of emergency department stay(length of stay will be calculated upto 24 hours)
研究者
Do Kyun Kim
assistant professor
Seoul National University Hospital
研究点 (1)
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