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:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT03931057
Eligibility Criteria:
Inclusion Criteria:
* ASA 1 and 2 children from 2-8 years scheduled for elective surgical or diagnostic procedures, where premedication would be used in clinical routine
* Signed written parental informed consent prior to inclusion in the study
Exclusion Criteria:
* ASA 3-5
* Allergy against the study drug
* Participation in another clinical study investigating another IMP within one month prior to screening
* Other objections to study participation in the opinion of the investigator
* Parent's or legal guardian's refusal of participation of the child
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
8 Years
Study:
NCT03931057
Study Brief:
Protocol Section:
NCT03931057