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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT02955732
Eligibility Criteria:
Inclusion Criteria:
* 1\. The child is scheduled for intra-articular drug injections, hernia repair, bronchoscopy or another similar minor procedure or magnetic resonance imaging requiring sedation or anesthesia
* 2\. Guardians and patient (if relevant) with fluent skills in the Finnish or Swedish language (to understand the given information, to be able to give informed consent and communicate with the study personnel).
* 3\. Age between 1 month and 12 years.
* 4\. Normal developmental status including growth (SD -1.5-1.5)
* 5\. Written informed consent from the guardian and the patient (when relevant).
Exclusion Criteria:
* 1\. A previous history of intolerance to the study drug or to related compounds and additives
* 2\. Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
* 3\. Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
* 4\. Existing or recent significant disease that could influence the study outcome or cause a health hazard for the subject if he/she would participate in the study.
* 5\. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* 6\. Clinically significant abnormal findings in physical examination or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Years
Study:
NCT02955732
Study Brief:
Protocol Section:
NCT02955732