Clinical trial NCT03052218: Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol
Official title: Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Drug Intolerance
Cytochrome P450 CYP2D6 Enzyme Deficiency
Drug Effect
Keywords: children
pain
Cytochrome P450 CYP2D6 genotype
Cytochrome P450 CYP2D6 phenotype
Pupillometry
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: pupillometry parameters and CYP2D6 phenotype
timeFrame: 0-6hours after tramadol administration
Secondary outcomes:
measure: pupillometry parameters and CYP2D6 genotype
timeFrame: 0-6hours after tramadol administration
measure: pupillometry parameters and tramadol concentration
timeFrame: 0-6hours after tramadol administration
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals, Geneva, Switzerland
Study officials:
affiliation: Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland
name: Frederique j Rodieux, MD
role: PRINCIPAL_INVESTIGATOR
References: