Trial intelligence / Profile preview

Buccal vs Intranasal Midazolam for Dental Anxiety

NCT04608734Phase 2

Key facts

Status: Completed
Start: Jun 2015
Primary completion: Jun 2016
Countries: 1
Modality: Small Molecules

Drugs: midazolam
Conditions: Dental anxiety

Overview

Phase 2, randomised trial of midazolam in Dental anxiety (2 arms). Primary endpoints: Acceptance of drug administration, Sleep score at 5 minutes and 3 more. Started Jun 2015; status: completed.

Design

2 arms

Study design: Randomized

Buccal midazolam
Midazolam spray administered via buccal route
Intranasal midazolam
Midazolam spray administered via intranasal route

Who it enrols

Pre-School children with negative/definitely negative behavior (Frankl scale) and at least two carious lesions requiring treatment. Must be ASA I or II.

Endpoints

Primary

Acceptance of drug administrationduring the sedation procedure
Sleep score5 minutes
Crying score5 minutes
Head/oral resistance score5 minutes
Overall behavior

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