Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

NCT ID: NCT03052218

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-06-30

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

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.

Conditions

Drug Intolerance; Cytochrome P450 CYP2D6 Enzyme Deficiency; Drug Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

single arm study

pupillometry, CYP2D6 genotyping and phenotyping

Group Type: EXPERIMENTAL

Pupillometry

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Frédérique Rodieux

Dr. Med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederique j Rodieux, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland

Locations

Geneva University Hospitals, Geneva, Switzerland

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2016-01936

Identifier Type: -

Identifier Source: org_study_id