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

University Hospitals (UH)

Status

Terminated

Conditions

Cytochrome P450 CYP2D6 Enzyme Deficiency

Drug Intolerance

Drug Effect

Treatments

Device: Pupillometry

Study type

Interventional

Funder types

Other

Identifiers

NCT03052218

2016-01936

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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