Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol (PUPICYP)
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|ClinicalTrials.gov Identifier: NCT03052218|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : May 3, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Drug Intolerance Cytochrome P450 CYP2D6 Enzyme Deficiency Drug Effect||Device: Pupillometry||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: single arm study
pupillometry, CYP2D6 genotyping and phenotyping
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
- pupillometry parameters and CYP2D6 phenotype [ Time Frame: 0-6hours after tramadol administration ]Correlation between pupillometry parameters and CYP2D6 phenotype
- pupillometry parameters and CYP2D6 genotype [ Time Frame: 0-6hours after tramadol administration ]Correlation between pupillometry parameters and CYP2D6 genotype
- pupillometry parameters and tramadol concentration [ Time Frame: 0-6hours after tramadol administration ]Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052218
|Contact: Frederique J Rodieux, MDfirstname.lastname@example.org|
|Contact: Flavia Storelliemail@example.com|
|Geneva University Hospitals, Geneva, Switzerland||Recruiting|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Frederique j Rodieux, MD||Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland|