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Comparison of three sedative agents; intranasal dexmedetomidine, intranasal midazolam and inhalation nitrous oxide for children undergoing dental treatment

Comparative evaluation of the efficacy of intranasal atomised dexmedetomidine, atomised midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041180
Enrollment
12
Registered
2022-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Intranasal midazolam: Given using an intranasal atomization device at a dose of 0.3 mg/kg Intervention2: Intranasal dexmedetomidine, Intranasal Midazolam: Given using an intranasal ato

Sponsors

Janiani Palak Ramesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA I Category 2.Behavior category: Frankl Scale 2 negative 3.Requiring pulpectomy in at least three posterior teeth in the lower arch 4.No cognitive impairment

Exclusion criteria

Exclusion criteria: 1.Patients who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam. 2.Children with any condition that predisposes them to airway obstruction or difficulties (eg adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp). 3.Frankl scale #1 (definitely negative) 4.Children with upper or lower respiratory tract infections 5. Children with special health care needs

Design outcomes

Primary

MeasureTime frame
Assessment of sedation and behaviour Intra- and Post-op painTimepoint: Assessment of sedation and behaviour Intra- and Post-op pain

Secondary

MeasureTime frame
Physiologic signs (Blood pressure, SPO2, Pulse rate) Recovery time Side effectsTimepoint: During administration of local anaesthesia, during insertion of mouth prop, during obturation Post treatment

Countries

India

Contacts

Public ContactDr Deepa Gurunathan

Saveetha Dental College and Hospitals

deepag@saveetha.com9994619386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026