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临床试验/NCT03052218
NCT03052218终止不适用

Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
50
试验地点
2
主要终点
pupillometry parameters and CYP2D6 phenotype

研究概览

简要总结

Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice per hour in children having received tramadol as a pain killer as part of his/her routine care.

Pupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score

详细描述

The proposed study is a single-center, observational and prospective study which will be conducted at the Pediatric Emergency Department, Geneva Children's Hospital.

This study will begin in January 2016 and will last one year. 53 patients are planned to be enrolled.

Children receiving oral tramadol as a pain killer at the emergency department, as part of their routine care, will be informed of the current study. Patients willing to participate will be included in the study after signing the inform consent (or respectively his/her parents or legal guardians). A unique oral dose of dextromethorphan (0.15 mg/kg) will be given to the participant for CYP2D6 phenotyping (T0).

Two hours later, capillary whole blood will be sampled to 1) measure the metabolic ratio dextrorphan/dextromethorphan (MRDOR/DEM) in order to determine CYP2D6 phenotype (validated metrics for CYP2D6 phenotyping), 2) measure tramadol and its active metabolite O-desmethyltramadol (M1), and 3) to genotype for CYP2D6. Saliva sample will also be performed to genotype for CYP2D6. Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice per hour, throughout the patient's stay at the emergency department.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
1 Year 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

pupillometry parameters and CYP2D6 phenotype

时间窗: 0-6hours after tramadol administration

Correlation between pupillometry parameters and CYP2D6 phenotype

次要结局

  • pupillometry parameters and CYP2D6 genotype(0-6hours after tramadol administration)
  • pupillometry parameters and tramadol concentration(0-6hours after tramadol administration)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frédérique Rodieux

Dr. Med

University Hospital, Geneva

研究点 (2)

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