Precedex Intravenous Solution Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Number of participants with adverse drug reactions (ADRs)
研究概览
简要总结
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
This study is seeking for children who are 1 month to less than 18 years old.
The patients are planned to be looked over:
- From the time of patient check before receiving Precedex
- To 1 hour after the completion or stop of using Precedex.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
排除标准
- •No exclusion criteria is set out in this study.
研究组 & 干预措施
Dexmedetomidine Hydrochloride
Pediatric patients (1 month to < 18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
Number of participants with adverse drug reactions (ADRs)
时间窗: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration
次要结局
未报告次要终点
