drugset / Trial / NCT06887712
Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Procedures
Phase 4
Completed
80 enrolled
Hanoi Medical University
Hanoi national hospital of odonto stomatology · collab
RandomizedParallel-groupTriple-blindTreatment
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
Timeline
- Start
- 2024-04-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 0.3 mg/kg | Oral |
| Subject | Midazolam | Small molecule | 0.6 mg/kg | Oral |
Indications
No indication recorded.