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

Conditions: In the context of the trial, the IMP is to be used as anaesthetic premedication in children undergoing elective routine surgery.(The medical condition for marketing is acute seizures in children aged 3 months - <18 years.)
MedDRA version: 9.1Level: LLTClassification code 10058073Term: Anaesthetic premedication

Registration Number: EUCTR2009-012808-11-DE

Lead Sponsor: Therakind Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the single dose pharmacokinetic profile of buccally administered midazolam in children from 3 months – <18 years.;Secondary Objective: To provide additional safety information (particularly buccal tolerability) to the current profile for buccal midazolam use.;Primary end point(s): - Pharmacokinetic parameters for midazolam and 1-hydroxy midazolam<br> <br>- Safety parameters:<br> - Adverse event monitoring<br> - Respiratory depression:<br> - Local tolerability:<br>

Secondary Outcome Measures