EUCTR2014-003269-46-NL进行中（未招募）1 期
Pediatric microdosing midazolam: elucidating age-related changes in oral drug absorption - PedMicMida
Erasmus MC - Sophia0 个研究点目标入组 60 人开始时间: 2015年2月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Age 0 to 6 years inclusive
- •-At least 36 weeks of post conceptual age or body weight 2.5 kg or more
- •-Receiving midazolam IV
- •-Parental informed consent
- •- Intravenous of intra-arterial access for blood sampling
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
排除标准
- •-Anticipated death in 48 hours
- •-No informed consent
- •-ECMO treatment
- •-Circulatory failure
- •* Receiving more than 1 vasporessor or
- •* Increase of vasopressor drug dose in the last 6 hours
- •-Chronic liver cirrhosis or chronic renal failure
- •-Renal failure according to the pRIFLE criteria, i.e. estimated creatinine clearance decreased by 75% or an urine output of <0.3 ml/kg/h for 24h or anuric for 12 hours.
- •-Acute liver failure AST/ALT >2 times the upper limit for age
- •-Gastrointestinal disorders: Ileus, diarrhoea, short bowel disease, underlying inflammatory bowel disease, pancreatic insufficiency (e.g. cystic fibrosis), celiac disease.
- •-Use of most relevant co-medication known to affect midazolam metabolism (according to the ‘Cytochrome P450 Drug Interactions Table’ )
- •Indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem, cimetidine , amiodarone, chloramphenicol, ciprofloxacin, delaviridine, diethyldithiocarbamate, fluvoxamine, gestodene, imatinib, mibefradil, mifepristone, norfloxacin, norfluoxetine, star fruit, voriconazole
- •Efavirenz, nevirapine, barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John’s wort, troglitazone
研究者
相似试验
已完成
不适用
Pediatric microdosing midazolam: elucidating age-related changes in oral drug absorptiointestinale absorptie en metabolisme van geneesmiddelen bij kritisch zieke kinderenIntestinal drug absorption and metabolism in critically ill childrenNL-OMON44350Erasmus MC, Universitair Medisch Centrum Rotterdam60
已完成
不适用
Pediatric Microdosing midazolam: elucidating age-related changes in oral drug absorptioMidazolam, ontogeny, children, absoprtion, metabolism.NL-OMON26131Erasmus Medical Center60
尚未招募
不适用
Age dependency of midazolam requirements in a pediatric intensive care unit: a prospective clinical studybetreft kinderen opgenomen op een kinder intensive care afdeling met een diversiteit aan aandoeningensleep medicationNL-OMON31394Vrije Universiteit Medisch Centrum28
已完成
不适用
Midazolam plasma concentration in children after anesthesia premedication in clinical routineChildren undergoing surgery in General anesthesiaDRKS00008736Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld20
已完成
不适用
Pediatric Microdosing paracetamol: elucidating age-relatedchanges in oral drug absorptioNL-OMON23846Erasmus MC60