Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

Overview

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

Full Title of Study: “Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

Detailed Description

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.

Interventions

  • Device: Pupillometry
    • Pupillometry performed before administration of tramadol, at T0 and then 1 to twice per hour, during the stay of the patient in the emergency department

Arms, Groups and Cohorts

  • Experimental: single arm study
    • pupillometry, CYP2D6 genotyping and phenotyping

Clinical Trial Outcome Measures

Primary Measures

  • pupillometry parameters and CYP2D6 phenotype
    • Time Frame: 0-6hours after tramadol administration
    • Correlation between pupillometry parameters and CYP2D6 phenotype

Secondary Measures

  • pupillometry parameters and CYP2D6 genotype
    • Time Frame: 0-6hours after tramadol administration
    • Correlation between pupillometry parameters and CYP2D6 genotype
  • pupillometry parameters and tramadol concentration
    • Time Frame: 0-6hours after tramadol administration
    • Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1

Participating in This Clinical Trial

Inclusion criteria

  • Age 1-15 year at time of inclusion – Weight ≥ 10 kg – Treatment with tramadol as a pain killer administrated as part of their routine care – Parent/Legal guardian has been informed about the study and has signed Informed Consent Form Exclusion criteria – Known kidney or liver disease – Concomitant treatment with inhibitors/inducers of CYP2D6 and CYP3A – Documented previous adverse reaction to tramadol or dextromethorphan – Concomitant treatment with any opiate drug and/or any drug with a known impact on pupil size – Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Geneva
  • Provider of Information About this Clinical Study
    • Principal Investigator: Frédérique Rodieux, Dr. Med – University Hospital, Geneva
  • Overall Official(s)
    • Frederique j Rodieux, MD, Principal Investigator, Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland

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