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Recruiting NCT07876024

Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy

Conditions: Dental Anxiety in Children, Child Behaviour

Sex: All
Ages: 4 Years – 8 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 68
Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Location: Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Islamabad Islamabad

Summary

The rationale of this trial is to evaluate whether combining intranasal atomized midazolam with nitrous oxide offers better behavior management leading to successful treatment completion in comparison with using nitrous oxide alone. If this combination works well, it can establish a reliable, non-invasive protocol to treat highly anxious and uncooperative pediatric patients safely. Additionally, studying the mucosal atomization device will confirm if this mist-like delivery reduces the nasal irritation and discomfort common with traditional drops. If this combined strategy proves successful, it will provide pediatric dentists with a predictable, stress-free outpatient technique that improves patient comfort without risking safety. Beyond these clinical benefits, this trial introduces an innovative framework that aligns advanced pediatric behavior management with "Green Dentistry" principles

Eligibility Criteria

Inclusion Criteria: * Children aged between 4 to 8 years old. * Dental anxiety confirmed by a baseline Frankl Behavior Rating Scale score of 1 (Definitely Negative) or 2 (Negative) during initial examination. * Healthy pediatric patients categorized under American Society of Anesthesiologists (ASA) class I or II physical status. * Confirmed patent nasal airway without active congestion, and verified compliance with standard ASA NPO (fasting) rules. * Planned dental interventions requiring local anesthesia confined to a maximum of two quadrants (e.g., pulpotomies, pulpectomies, stainless steel crowns, or uncomplicated primary extractions). * Expected operational duration spanning 20 to 30 minutes, with a definitive termination threshold at 45 minutes. * Provision of signed, informed written consent by a parent or legal guardian. Exclusion Criteria: * Pathological nasal airway obstructions, severely enlarged adenoids, or active upper respiratory tract infections. * Mouth breathers or patients with structural craniofacial anomalies impeding proper nasal hood adaptation * Known systemic contraindications or allergies to benzodiazepines, nitrous oxide or local anesthetic agents. * Severe tonsillar hypertrophy classified as Class 3 or Class 4 on the Brodsky Scale, introducing airway obstruction risks. * Cognitive, developmental, or psychological delays that impair standard behavioral monitoring scales.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07876024). StuddyBuddy aggregates publicly available trial information.