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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT03052218

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Drug Intolerance Cytochrome P450 CYP2D6 Enzyme Deficiency Drug Effect	Device: Pupillometry	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

pupillometry parameters and CYP2D6 phenotype [0-6hours after tramadol administration]
Correlation between pupillometry parameters and CYP2D6 phenotype

Secondary Outcome Measures

pupillometry parameters and CYP2D6 genotype [0-6hours after tramadol administration]
Correlation between pupillometry parameters and CYP2D6 genotype
pupillometry parameters and tramadol concentration [0-6hours after tramadol administration]
Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals, Geneva, Switzerland	Geneva		Switzerland	1205

Sponsors and Collaborators

University Hospital, Geneva

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frédérique Rodieux, Dr. Med, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT03052218

Other Study ID Numbers:

2016-01936

First Posted:

Feb 14, 2017

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Frédérique Rodieux, Dr. Med, University Hospital, Geneva

children

pain

Cytochrome P450 CYP2D6 genotype

Cytochrome P450 CYP2D6 phenotype

Pupillometry

Study Results

No Results Posted as of Jun 1, 2022