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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT05894057
Eligibility Criteria:
Inclusion Criteria:
* Children from 2 years (meaning 2 years 0/12 months) to younger than 10 years (meaning 9 years 12/12 months) of age at the time of surgery
* Children scheduled for ambulatory or elective surgery or for procedures requiring anxiolysis at the UKBB
* Children qualifying as American Society of Anesthesiologists (ASA) 1 or ASA 2 patients
* Clinically indicated administration of midazolam oral syrup, rectal suppository or ODMT
* Parent or legal guardian has been informed about the study and has signed the Informed Consent Form
Exclusion Criteria:
* Children qualifying as ASA 3 and above patients
* Children arriving at the emergency ward in a critically ill condition which needs immediate intervention (i.e. American Thoracic Society (ATS) Score 1 and 2) and no tolerance for time delay due to informed consent.
* Difficulty in assessing palatability due to neurological impairments
* Hypersensitivity to midazolam, other benzodiazepines, or any formulation excipients
* Hypersensitivity to cherries (syrup)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT05894057
Study Brief:
Protocol Section:
NCT05894057