Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT03052218
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
15 Years
Study:
NCT03052218
Study Brief:
Protocol Section:
NCT03052218