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The Use of ADV6209 for Premedication in Pediatric Anesthesia

NCT03931057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-16

No results posted yet for this study

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

Conditions

  • Preanesthetic Medication

Interventions

DRUG

ADV6209 (=gamma-cyclodextrin-Midazolam)

30 min. before anesthesia children have to swallow the anxiolytic drug (ADV6209)

DRUG

Midazolam

30 min. before anesthesia children have to swallow the anxiolytic drug Midazolam

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Peter Marhofer, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-09-17
Completion
2021-09-17

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931057 on ClinicalTrials.gov