Intranasal Midazolam Plus Nitrous Oxide for Anxious Kids Compared to Nitrous Oxide Alone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial compares two sedation approaches in anxious children aged 4–8 requiring limited dental procedures. Children are assigned to receive either intranasal atomized midazolam with nitrous oxide or nitrous oxide alone, with outcomes including treatment success, mask acceptance, behavior during the procedure, recovery time, and adverse events. The study uses validated scales to measure behavior and recovery and is conducted at SZABMU in Islamabad over a three-month period after IRB approval. The mucosal atomization device is evaluated for comfort and nasal irritation, aiming to establish a predictable, non-invasive outpatient technique aligned with Green Dentistry principles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Islamabad
  Islamabad, Pakistan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.