Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol
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
- 否
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
Frédérique Rodieux
Dr. Med
University Hospital, Geneva
