NCT02955732已完成4 期
Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Relative bioavailability (%) of intranasally given dexmedetomidine
研究概览
简要总结
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
- •Age between 1 month and 12 years.
- •Normal developmental status including growth (SD -1.5-1.5)
- •Written informed consent from the guardian and the patient (when relevant).
排除标准
- •A previous history of intolerance to the study drug or to related compounds and additives
- •Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
- •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.
- •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.
- •Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- •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)].
研究组 & 干预措施
Intranasal dex
Experimental
Dexmedetomidine 2-4 µg/kg alone
干预措施: Dexmedetomidine (Device)
结局指标
主要结局
Relative bioavailability (%) of intranasally given dexmedetomidine
时间窗: 4 hours
次要结局
- Number of patients with adverse events as a measure of safety and tolerability(6 hours)
- Change in hemodynamic parameter (blood pressure)(6 hours)
- Change in hemodynamic parameter (heart rate)(6 hours)
研究者
研究点 (2)
Loading locations...
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