Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

NCT03052218 | Terminated DMC

• 1 other identifier: 2016-01936
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Drug Intolerance; Cytochrome P450 CYP2D6 Enzyme Deficiency; Drug Effect

Keywords

children; pain; Cytochrome P450 CYP2D6 genotype; Cytochrome P450 CYP2D6 phenotype; Pupillometry

Outcome Measures

Primary Outcomes (1)

• pupillometry parameters and CYP2D6 phenotype

  Correlation between pupillometry parameters and CYP2D6 phenotype

  0-6hours after tramadol administration

Secondary Outcomes (2)

• pupillometry parameters and CYP2D6 genotype

  0-6hours after tramadol administration

• pupillometry parameters and tramadol concentration

  0-6hours after tramadol administration

Study Arms (1)

single arm study

EXPERIMENTAL

pupillometry, CYP2D6 genotyping and phenotyping

Device: Pupillometry

Interventions

Pupillometry 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

single arm study

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals, Geneva, Switzerland

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederique j Rodieux, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)