Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Procedures

PHASE4CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Dental Anxiety
Interventions
DRUG

Oral midazolam

The intravenous formulation Midazolam Braun 5 mg/ml (B. Braun Melsungen AG, Germany) diluted and mixed with orange juice for oral administration at doses of 0.3 mg/kg , administered approximately 30 minutes before pediatric dental procedures. Sedation and amnesic effects, behavioral cooperation during treatment, sedation onset time, vital signs, recovery duration, safety, and adverse events are systematically monitored and compared between the two dosing groups.

DRUG

Oral midazolam

The intravenous formulation Midazolam Braun 5 mg/ml (B. Braun Melsungen AG, Germany) diluted and mixed with orange juice for oral administration at doses of 0.6 mg/kg, administered approximately 30 minutes before pediatric dental procedures. Sedation and amnesic effects, behavioral cooperation during treatment, sedation onset time, vital signs, recovery duration, safety, and adverse events are systematically monitored and compared between the two dosing groups.

Trial Locations (1)

100000

Hanoi Medical Univeristy, Hanoi

All Listed Sponsors
collaborator

Hanoi national hospital of odonto stomatology

UNKNOWN

lead

Hanoi Medical University

OTHER

NCT06887712 - Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Procedures | Biotech Hunter | Biotech Hunter