Bioavailability and pharmacokinetics of intranasal dexmedetomidine in children

niversity of Turku0 个研究点目标入组 50 人开始时间: 2016年10月17日最近更新: 2020年10月19日

试验速览

暂无简介。

•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 patients (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).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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)].

发起方

niversity of Turku