Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Proce… (NCT06887712) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Oral Midazolam for Sedation and Amnesia in Preschool Children Undergoing Dental Procedures
Vietnam80 participantsStarted 2024-04-01
Plain-language 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
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sedation Effectiveness
Timeframe: Within 30 minutes after oral midazolam administration
2
Amnesic Effectiveness (Memory Assessment)
Timeframe: 12 hours, 24 hours, and 1 week after the dental procedure