Posted by A recently posted phase 2 clinical trial (not yet recruiting) aims to evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesia. The primary objective is: Sedation score (mYPAS) 30 min after administration of the premedication drug, the secondary objective: acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug.
In the formulation, midazolam is formulated with gamma-cyclodextrin in the form of an orange flavoured syrup. The study is expected to start this June and last until June 2020.