A Phase 4 interventional study of Oral midazolam and Oral midazolam in Dental Anxiety, sponsored by Hanoi Medical University. Completed at 1 site in Vietnam. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Hanoi Medical University · Phase 4, Interventional, and Treatment
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
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 oral health, negatively impacting children and their families. Behavioral management techniques, such as positive reinforcement, are typically employed but may be insufficient for severely anxious patients. Pharmacological sedation, especially with midazolam-a short-acting benzodiazepine-is commonly used to enhance cooperation by providing sedation, anxiety relief, and amnesia. Oral midazolam administration is widely preferred for children due to its non-invasive nature, despite slower onset and variable bioavailability. Current guidelines recommend oral midazolam doses between 0.25 and 1 mg/kg; however, optimal dosing balancing effectiveness and safety remains unclear.
Recognizing this gap, this randomized controlled trial aims to compare two oral midazolam doses (0.3 mg/kg versus 0.6 mg/kg) in preschool children aged 3-6 years who exhibit dental anxiety. Conducted from June to December 2024 at the National Hospital of Odonto-Stomatology in Hanoi, Vietnam, this prospective, double-blind study enrolls 80 pediatric patients who meet strict inclusion and exclusion criteria. Children included have significant dental anxiety, assessed as "negative" or "definitely negative" based on the Frankl Behavior Rating Scale, normal body weight, and an ASA (American Society of Anesthesiologists) physical status of I or II. Patients with systemic diseases, cognitive impairments, severe respiratory conditions, liver or kidney dysfunction, mental disorders (e.g., autism, ADHD), or allergies to sedatives are excluded from participation.
Participants are randomly assigned using block randomization into two groups receiving either 0.3 mg/kg or 0.6 mg/kg oral midazolam. Blinding ensures dentists performing procedures and data collectors remain unaware of dosing specifics to minimize bias. Sedation effectiveness is measured using the Ramsay Sedation Scale (RSS), with successful sedation defined as achieving RSS score 3 ("awake but responds to commands only") within 30 minutes post-administration. Children not reaching this sedation level within the specified timeframe are excluded from further analysis.
Vital signs, including heart rate and oxygen saturation, are closely monitored throughout the procedure. Patient behavior during dental treatment is assessed using the Houpt Behavior Rating Scale, which evaluates sleepiness, movement, and crying. The study also investigates midazolam's amnesic effects through structured memory assessments conducted 12 hours, 24 hours, and one week post-procedure.
Additionally, safety assessments monitor adverse events such as respiratory depression, hypotension, excessive sedation, nausea, and vomiting during sedation and 24 hours afterward. The collected data undergo statistical analysis using SPSS software, employing independent t-tests for continuous variables (e.g., sedation onset time, treatment duration, recovery time) and chi-square or Fisher's exact tests for categorical variables (e.g., sedation success rates, amnesia outcomes). A significance threshold is established at p\<0.05.
Through detailed evaluation of sedation efficacy, amnesic effect, patient safety, and procedural cooperation, this research seeks to clarify optimal midazolam dosing strategies, contributing to improved clinical practices, reduced dental anxiety, and better overall pediatric dental experiences.
22 studies on the registry are indexed under Amnesia; 2 are open to participants now.
This study's enrollment of 80 is above the median of 62 across 19 interventional studies indexed under Amnesia.
Browse Amnesia studies →Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: Oral Midazolam 0.3 mg/kg Children aged 3-6 years with dental anxiety receive oral midazolam at a dose of 0.3 mg/kg prior to dental procedures. Sedative and amnesic effects, patient cooperation, and safety outcomes are evaluated.
Drug: Oral midazolam
Arm 2: Oral Midazolam 0.6 mg/kg Children aged 3-6 years with dental anxiety receive oral midazolam at a dose of 0.6 mg/kg prior to dental procedures. Sedative and amnesic effects, patient cooperation, and safety outcomes are assessed and compared to the lower dose group.
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.
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.
Sedation Effectiveness
Sedation effectiveness is measured using the Ramsay Sedation Scale (RSS), a standardized 6-point scale evaluating sedation depth. Successful sedation is defined as achieving an RSS score of 3 (awake but responds to commands only) within 30 minutes after administration of oral midazolam. Children not reaching RSS score ≥3 within 30 minutes are classified as having unsuccessful sedation.
Time frame: Within 30 minutes after oral midazolam administration
Amnesic Effectiveness (Memory Assessment)
The ability of pediatric patients to recall details of the dental procedure will be assessed through a structured verbal questionnaire conducted via video call at 12 hours, 24 hours, and one week post-procedure. The assessment aims to determine and compare the amnesic effects between two oral midazolam doses (0.3 mg/kg vs. 0.6 mg/kg)
Time frame: 12 hours, 24 hours, and 1 week after the dental procedure
Sedation Onset Time
The interval (minutes) from administration of oral midazolam to achieving a sedation score of 3 on the Ramsay Sedation Scale
Time frame: Up to 30 minutes after drug administration
Patient Behavior During Dental Procedure
Behavior of pediatric patients during the dental procedure will be assessed using the Houpt Behavior Rating Scale, evaluating levels of sleepiness, movement, crying, and overall cooperation. Ratings range from 1 (aborted) to 6 (excellent cooperation).
Time frame: During the dental procedure
Recovery Time (PADSS ≥9)
Recovery time measured from completion of the dental procedure until patients achieve a Post-Anesthetic Discharge Scoring System (PADSS) score of 9 or higher.
Time frame: Immediately following procedure until PADSS score ≥9 is achieved
Safety and Adverse Events
Incidence and severity of adverse events, including respiratory depression, hypotension, nausea, vomiting, or excessive sedation occurring during and up to 24 hours post-sedation.
Time frame: During the procedure and within 24 hours post-procedure
Vital Signs Monitoring
Heart rate and peripheral oxygen saturation (SpO₂) will be monitored and recorded at baseline (pre-sedation, T0), immediately after midazolam administration (T1), and subsequently at intervals of 5 minutes (T2), 10 minutes (T3), 20 minutes (T4), and post-dental procedure (T5), to evaluate safety and physiological response to sedation.
Time frame: Baseline (T0), immediately after administration (T1), 5 minutes (T2), 10 minutes (T3), 20 minutes (T4), and post-procedure (T5)
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam
Hanoi Medical University