Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol (PUPICYP)

Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol

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

Study Overview

• Status: Terminated
• Conditions: Drug Effect; Drug Intolerance; Cytochrome P450 CYP2D6 Enzyme Deficiency
• Intervention / Treatment: Device: Pupillometry

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals, Geneva, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single arm study; pupillometry, CYP2D6 genotyping and phenotyping	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupillometry parameters and CYP2D6 phenotype	Correlation between pupillometry parameters and CYP2D6 phenotype	0-6hours after tramadol administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Frederique j Rodieux, MD, Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pain; children; Pupillometry; Cytochrome P450 CYP2D6 genotype; Cytochrome P450 CYP2D6 phenotype
• Other Study ID Numbers: 2016-01936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No