To evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesia
Conditions
Interventions
Trade Name: Ozalin
Product Name: Ozalin
Product Code: ADV6209
Pharmaceutical Form: Oral solution in single-dose container
INN or Propose
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesia Primary Objective: Sedation score (mYPAS) 30 min after administration of the premedication drug ; Secondary Objective: Secondary Objective: Acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug ;Primary end point(s): Sedation score (mYPAS) after administration of the premedication drug;Timepoint(s) of evaluation of this end point: The level of sedation will be graded for each child 1 minute before oral administration of the study drug(s) and 5, 10, 15, and 30 min after premedication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objective: Acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug ; Timepoint(s) of evaluation of this end point: Acceptance of anaesthesia mask induction - is evaluated when anesthesia is induced in the operation room. Acceptance of oral administration of the premedication drug - is evaluated when the children shallow the premedication drug | — |
Countries
Austria
Contacts
Public ContactDept. of Paediatric Anaesthesia
Medical University of Vienna
Outcome results
None listed