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Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
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
Official title: Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy for Behaviour Management in Anxious Pediatric Dental Patient: a Randomized Control Trial
Key Details
Gender
All
Age Range
4 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-10-15
Completion Date
2027-01-30
Last Updated
2026-10-15
Healthy Volunteers
Yes
Interventions
Midazolam (Intranasal)
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.
Nitrous oxide/oxygen inhalation sedation alone
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 normal saline placebo
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.
Locations (1)
Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU) Islamabad
Islamabad, Pakistan