An open label, single dose, pharmacokinetic study of oromucosal midazolam administered to children from 3 months to less than 18 years undergoing routine elective surgery - Midazolam PK

Therakind Limited0 个研究点目标入组 75 人开始时间: 2009年8月7日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•1. Male or female aged from 3 months – <18years of age.
•2. Attending the hospital for routine elective surgery
•3. In the clinical opinion of the clinician in charge, the child requires midazolam for pre-medication treatment.
•4. Parent(s) or legal guardian in attendance.
•5. Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study.
•6. Where applicable, the child should assent to undergo blood sampling for pharmacokinetic purposes and to allow physiological measurements to be made.
•7. American Society of Anesthesiologists (ASA) classification of illness score of 2 or less
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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. Known allergy to benzodiazepine medications.
•2. Exposure to benzodiazepines (including midazolam) in the preceding 7 days.
•3. Exposure to drugs known to pharmacokinetically interact with midazolam in the preceding 7 days.
•4. Receiving any chronic medication, except inhaled asthma therapies. Patients that have received periodic simple analgesics such as paracetamol, ibuprofen etc will not be excluded.
•5. Participation in this or any clinical study in the previous 30 days or scheduled to receive any other investigational drug during the course of the study.
•6. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study.
•7. Females who are pregnant, lactating or planning to become pregnant.
•8. Patients with a known history of epilepsy

发起方

Therakind Limited