Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

Not Applicable

Terminated

• Conditions: Drug Intolerance; Cytochrome P450 CYP2D6 Enzyme Deficiency; Drug Effect
• Interventions: Device: Pupillometry

• Registration Number: NCT03052218
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-14
• Study Start: 2017-03-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	Pupillometry	pupillometry, CYP2D6 genotyping and phenotyping

Primary Outcome Measures

Name	Time	Method
pupillometry parameters and CYP2D6 phenotype	0-6hours after tramadol administration	Correlation between pupillometry parameters and CYP2D6 phenotype

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geneva University Hospitals, Geneva, Switzerland; 🇨🇭 Geneva, Switzerland