THE USE OF NEW ORAL SOLUTION FOR THE TREATMENT OF ANXIETY AND STRESS BEFORE A NARCOSIS IN CHILDRE
Phase 1
- Conditions
- To evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesiaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-001853-25-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
•ASA 1 and 2 children from 2-8 years scheduled for elective surgical or diagnostic procedures
•Signed written parental informed consent prior to inclusion in the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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
•ASA 3-5
•Allergy against the study drug
•Participation in another clinical study investigating another IMP within 1 month prior to screening
•Other objections to study participation in the opinion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method