Comparative Evaluation of Two Sedatives in Pediatric Dental Procedure - A Randomized Clinical Trial

Comparative Evaluation of Intranasal Midazolam and Dexmedetomidine in Pediatric Dental Procedure - A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040572

Enrollment

Registered

2022-02-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Dexmedetomidine: 1.5Âµg/kg given Intranasally once at the beginning of the procedure Duration of the procedure - 2 hours Control Intervention1: Midazolam: 0.5mg/kg, given Intranasally

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing treatment for the first time. Patient who exhibit anxious behavior in Frankel behavior rating scale ( score 1 & 2) Requiring two dental procedures under local anaesthesia.

Exclusion criteria

Exclusion criteria: Patients who do not exhibit anxious behaviour on baseline anxiety scale. Patients with any systemic disease or drug allergy.

Design outcomes

Primary

Measure	Time frame
Dexmedetomidine is a better anxiolytic and sedative agent than MidazolamTimepoint: Baseline, During procedure (45 mins) and After procedure (2 hours).	—

Secondary

Measure	Time frame
Intranasal Dexmedetomidine is more effective than MidazolamTimepoint: Baseline, During procedure (45 mins) and After procedure (2 hours)	—

Countries

India

Contacts

Public ContactDr Kavya R Shah

Narsinhbhai Patel Dental College and Hospital

vshobaf@gmail.com7708535361

Outcome results

None listed

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