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

NCT06887712 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-25

No results posted yet for this study

Summary

Dental anxiety frequently impedes effective dental care in pediatric patients. This study aimed to compare the efficacy and safety of two doses (0.3 mg/kg and 0.6 mg/kg) of oral midazolam for sedation and amnesia in preschool children undergoing dental procedures. Methods: This prospective, double-blind, randomized controlled trial included 80 children aged 3-6 years with dental anxiety. Participants were randomly assigned to receive oral midazolam at either 0.3 mg/kg or 0.6 mg/kg. Sedation efficacy, onset time, procedure duration, cooperation level (Houpt Behavior Rating Scale), recovery time, amnesia at 12 hours, 24 hours, and one week, as well as adverse events, were recorded and analyzed

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.

Sponsors & Collaborators

  • Hanoi national hospital of odonto stomatology

    collaborator UNKNOWN

  • Hanoi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Vietnam

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 NCT06887712 on ClinicalTrials.gov