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

NCT06887712 | Completed Phase 4 DMC

• 1 other identifier: NCSPQKRHM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Keywords

Oral Midazolam; Sedation; Amnesia; Pediatric Dentistry,

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  12 hours, 24 hours, and 1 week after the dental procedure

Secondary Outcomes (5)

• Sedation Onset Time

  Up to 30 minutes after drug administration

• Patient Behavior During Dental Procedure

  During the dental procedure

• Recovery Time (PADSS ≥9)

  Immediately following procedure until PADSS score ≥9 is achieved

• Safety and Adverse Events

  During the procedure and within 24 hours post-procedure

• Vital Signs Monitoring

  Baseline (T0), immediately after administration (T1), 5 minutes (T2), 10 minutes (T3), 20 minutes (T4), and post-procedure (T5)

Study Arms (2)

Arm 1: Oral Midazolam 0.3 mg/kg

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Oral midazolam DRUG

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.

Arm 1: Oral Midazolam 0.3 mg/kg

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead
• Hanoi national hospital of odonto stomatology: collaborator

Study Sites (1)

Hanoi Medical Univeristy

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Amnesia

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)