Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

Drug Effect Clinical Trial

— PUPICYP  

Official title:

Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052218
• Other study ID #: 2016-01936
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytochrome P450 CYP2D6 Enzyme Deficiency
• Drug Effect
• Drug Intolerance

Intervention

Device:
• 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

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals, Geneva, Switzerland	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillometry parameters and CYP2D6 phenotype	Correlation between pupillometry parameters and CYP2D6 phenotype	0-6hours after tramadol administration
Secondary	pupillometry parameters and CYP2D6 genotype	Correlation between pupillometry parameters and CYP2D6 genotype	0-6hours after tramadol administration
Secondary	pupillometry parameters and tramadol concentration	Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1	0-6hours after tramadol administration