To compare the anxiety reducing effect of two oral medicines for uncooperative children during dental procedures

Comparative evaluation of the anxiolytic effect and emergence of delirium with oral dexmedetomidine and oral midazolam in 3-7 year old uncooperative children for dental procedures: A randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059366

Enrollment

115

Registered

2023-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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 Dexmedetomidine: Anxiolytic Medicatiob Dose for Group 3-Dexmedetomidine (4µg/Kg)(DM1) Dose for Group 5- Dexmedetomidine (2µg/Kg) (DM2) frequency would be single dose administrat

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 3-7 years of age. ? Children’s behaviour class I and II according to Frankl behavior rating scale. ? Children with ASA I health status. ? Preoperative heart rate of 80 to 140 beats per minute and Respiratory rate of 24-30 beats per minute. ? A maximum blood pressure reading of 140/100 mmHg. ? Patients who require LA administration for dental procedures.

Exclusion criteria

Exclusion criteria: Patient with any chronic systemic illness. ? A history of allergy or intolerance to benzodiazepines. ? Parents who did not give consent

Design outcomes

Primary

Measure	Time frame
ANXIOLYSIS PAIN CONTROLTimepoint: 1 WEEK	—

Secondary

Measure	Time frame
PSYCHOMOTOR EFFECTTimepoint: 1 WEEK	—

Countries

India

Contacts

Public ContactDr Anshula Deshpande

K M SHAH DENTAL COLLEGE AND HOSPITAL

dranshula@gmail.com7600916400

Outcome results