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临床试验/NCT04350528
NCT04350528Unknown不适用

Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2020年4月30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
入组人数
254
试验地点
1
主要终点
Sedation success

研究概览

简要总结

Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Sedation for the purpose of imaging
  • Sedation using chlorpromazine or pentobarbital

排除标准

  • Refusal to participate

研究组 & 干预措施

Chlorpromazine

干预措施: Chlorpromazine or Pentobarbital (Drug)

Pentobarbital

干预措施: Chlorpromazine or Pentobarbital (Drug)

结局指标

主要结局

Sedation success

时间窗: During the procedure

Imaging purpose is answered

次要结局

  • Induction time(During the procedure)
  • Hospitalization duration(Through procedure completion)
  • Duration of the imaging procedure(During the procedure)
  • Secondary effects(From Procedure until 2 days after)
  • Failure of pentobarbital sedation in children with a behavioral disorder(During the procedure)
  • Failure of pentobarbital sedation in children older than 5 years(During the procedure)
  • Failure of pentobarbital sedation in children under chronic antiepileptic treatment(During the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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