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临床试验/NCT06085573
NCT06085573已完成不适用

Precedex Intravenous Solution Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)

Pfizer1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2023年10月18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
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

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

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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