Status:
COMPLETED
Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Procedures
Lead Sponsor:
Hanoi Medical University
Collaborating Sponsors:
Hanoi national hospital of odonto stomatology
Conditions:
Dental Anxiety
Eligibility:
All Genders
3-6 years
Phase:
PHASE4
Brief 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...
Detailed Description
Dental anxiety is common among preschool-aged children, with prevalence rates ranging from 36.5% to 70%. Untreated anxiety often leads to delayed dental care, increased dental caries, and worsened ora...
Eligibility Criteria
Inclusion
- Children aged 3 to 6 years.
- Diagnosed with dental anxiety classified as "definitely negative" or "negative" based on the Frankl Behavior Rating Scale.
- Normal weight range.
- Classified as ASA I or ASA II (American Society of Anesthesiologists Physical Status Classification).
Exclusion
- Endocrine disorders, severe respiratory diseases, or heart diseases.
- Mental health conditions such as autism, ADHD, or schizophrenia.
- Abnormal brain development or cognitive impairments.
- Liver or kidney dysfunction.
- Known allergies to benzodiazepines, opiates, etomidate, propofol, ketamine, or other medications used in the study.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06887712
Start Date
April 1 2024
End Date
December 31 2024
Last Update
March 25 2025
Active Locations (1)
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1
Hanoi Medical Univeristy
Hanoi, Vietnam, 100000