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 range

1 Year – 15 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

1 Year – 15 Years

Sex

ALL

See this in plain English?

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