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Comparison of three sedation methods to improve comfort during dental treatment in children.

Sedation Spectrum: Navigating Pediatric Comfort With Oral Midazolam, Intranasal Midasolam And Nitrous Oxide In Pediatric Dentistry. - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104747
Enrollment
90
Registered
2026-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Oral Midazolam: Injection iv/im midazolam liquid mixed with glucose in dose of 0.5mg/kg. Intervention2: Intranasal Midazolam: Intranasal Midazolam in form of spray given in dose of 0.2m

Sponsors

Dr. Rajal Udaybhai Dave
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Children aged 4 to 10 years 2 ASA 1 score & Frankl behavior rating 2 3 Need to undergo dental procedure like pulpectomy under local anesthesia 4 In whom non pharmacological behavior technique have not been successful

Exclusion criteria

Exclusion criteria: 1 Who would not be cleared by anesthetist for sedation 2 Any known allergy or hypersensitivity reaction to the drugs being used 3 Who would be given any analgesics 6 hours before the procedure 4 Who would be recently administered drugs like erythromycin, clarithromycin, fluconazole or anticonvulsants which interfere with pharmacokinetics of midazolam 5 Any known case of any type of systemic medical illness like breathing difficulties, cognitive impairment, etc

Design outcomes

Primary

MeasureTime frame
Oral and intranasal midazolam are expected to provide similar anxiolysis and sedation in children, though oral administration may show better acceptance. Oral midazolam and nitrous oxide are anticipated to have comparable clinical success in reducing anxiety. Intranasal midazolam may be as effective as nitrous oxide and serve as an alternative when mask tolerance is poor.Timepoint: At baseline

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Rajal Udaybhai Dave

Department of Pediatric and Preventive Dentistry,Government Dental College And Hospital, Ahmedabad

shandent1@gmail.com9825666575

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026