CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Buccal midazolam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04608734
NCT04608734Phase 2Completed
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Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients

Nourhan M.Aly·interventional·Posted Oct 29, 2020·Updated Oct 29, 2020

In Brief

A Phase 2 clinical trial evaluating Buccal midazolam and Intranasal midazolam for Dental Anxiety. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Anxiety
CountriesEgypt
CollaboratorsAlexandria University

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2020
Enrollment StartJun 10, 2015
Primary CompletionJun 13, 2016
Study CompletionJun 25, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.7 years ago

Interventions

Buccal midazolamdrug

The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.

Intranasal midazolamdrug

Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.