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

NCT07876024 | Not Yet Recruiting

• 1 other identifier: SOD/ERB/2026/111
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dental Anxiety in Children; Child Behaviour

Keywords

dental anxiety; behaviour mnagement; nitrous oxide; intranasal midazolam; inhalation sedation; consious sedation; Houpt scale; Frankl scale; Randomized controlled trial; Mucosal atomization device; pediatric dentistry

Outcome Measures

Primary Outcomes (1)

• To evaluate and compare the treatment success rates between a combined regimen of intranasal atomized midazolam with nitrous oxide versus nitrous oxide alone in anxious pediatric dental patients.

  Treatment success, defined as completion of all planned dental procedures during one appointment with a Houpt Overall Behavior Score of 4-6, without active physical restraint, rescue medication, or premature termination because of unmanageable child behavior.

  During the dental procedure, from treatment initiation until completion or termination.Expected operational duration spanning 20 to 30 minutes, with a definitive termination threshold at 45 minutes.

Study Arms (2)

Intranasal midazolam + nitorus oxide

EXPERIMENTAL

Intranasal atomized midazolam administered through a mucosal atomization device at the dose and concentration specified in the approved protocol, combined with titrated nitorus oxide/oxygen inhalation sedation.

Drug: Midazolam (Intranasal); Drug: Nitrous oxide/oxygen inhalation sedation alone

Nitrous oxide alone

ACTIVE COMPARATOR

Intranasal saline/placebo admisnistration throughh the same device, with the identical nitrous oxide/oxygen protocol.

Drug: Nitrous oxide/oxygen inhalation sedation alone; Other: Intranasal normal saline placebo

Interventions

Midazolam (Intranasal) DRUG

Midazolam will be administered intranasally using a mucosal atomization device (MAD) before the dental procedure. The dose will be 0.2 mg/kg of body weight, using the concentration and maximum dose specified in the approved protocol. The calculated volume will be divided between both nostrils. Following the specified waiting period, nitrous oxide/oxygen inhalation sedation will be administered according to the study protocol.

Intranasal midazolam + nitorus oxide

Nitrous oxide/oxygen inhalation sedation alone DRUG

Nitrous oxide/oxygen inhalation sedation will be administered by nasal hood after intranasal study preparation. Nitrous oxide will be titrated according to the approved protocol while oxygen delivery and clinical monitoring are maintained. At completion of treatment, nitrous oxide will be discontinued and 100% oxygen will be administered according to the institutional sedation protocol.

Intranasal midazolam + nitorus oxide; Nitrous oxide alone

Intranasal normal saline placebo OTHER

A matched volume of 0.9% normal saline will be administered intranasally using the same mucosal atomization device and administration method as the midazolam preparation. Participants will subsequently receive the same nitrous oxide/oxygen inhalation sedation protocol used in the experimental arm.

Nitrous oxide alone

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Islamabad

Islamabad, 44090, Pakistan

Location

MeSH Terms

Interventions

Midazolam; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical research associate

Model Details: 2 arms, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 15, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)