At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
Midazolam group (MDZ) +2 moredrug
Likely dose
Midazolam group (MDZ) 15mgfrom 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.
Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Midazolam group (MDZ), Dexmedetomidine group (DEX), and 1 other intervention for Dental Anxiety. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Anxiety
CountriesEgypt
CollaboratorsAlexandria University
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedFeb 2019
Primary CompletionAug 2019
Study CompletionDec 2019
TodayJul 2026
First PostedFeb 1, 2019
Enrollment StartNov 27, 2017
Primary CompletionAug 29, 2019
Study CompletionDec 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago
Interventions
Midazolam group (MDZ)drug
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
Dexmedetomidine group (DEX)drug
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)drug
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(