TerminatedNot Applicable

Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

Stopped: difficulties in recruitment

Switzerland50 participantsStarted 2017-03-01

Plain-language 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

Who can participate

Age range1 Year – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

pupillometry parameters and CYP2D6 phenotype

Timeframe: 0-6hours after tramadol administration

Trial details

NCT IDNCT03052218

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Drug Intolerance trials