The Use of ADV6209 for Premedication in Pediatric Anesthesia

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Anesthetics; Midazolam

Criteria

Inclusion Criteria:

• ASA 1 and 2 children from 2-8 years scheduled for elective surgical or diagnostic procedures, where premedication would be used in clinical routine

• Signed written parental informed consent prior to inclusion in the study

Exclusion Criteria:

• ASA 3-5

• Allergy against the study drug

• Participation in another clinical study investigating another IMP within one month prior to screening

• Other objections to study participation in the opinion of the investigator

• Parent's or legal guardian's refusal of participation of the child