Comparative Evaluation Of Two Intranasal sleep inducing/calming Agents Among Children Undergoing Invasive Dental Procedures

Comparative Evaluation Of Two Intranasal Sedative Agents Among Children Undergoing Invasive Dental Procedures: A Crossover Split Mouth Randomized Clinical Trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069940

Enrollment

Registered

2024-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Intranasal Dexmedetomidine: 1 minute after Internasal application with atomization device which is monitored for 3 days Control Intervention1: Intranasal midazolam: 1 minute after appli

Eligibility

Inclusion criteria

Inclusion criteria: Anxious paediatric patients aged 4â??10 years with negative and definitely negative behavioural rating. Belonging to American society of Anaesthesiologists (ASA) physical status I. Whose treatment requires bilateral pulp therapy (pulpotomy/pulpectomy) in lower two quadrants under inferior alveolar nerve block. Whose treatment requires bilateral extraction in lower two quadrants under inferior alveolar nerve block Children with no enlarged tonsils, no problem with neck movements and no oversized tongue. Children with optimal SpO2 saturation. Treatment modality only for first or second primary molars on both the sides

Exclusion criteria

Exclusion criteria: Children with cognitive impairment Breathing difficulties, History of systemic illness, Hypersensitivity to midazolam/ Children with congenital heart disease. Children on central nervous system (CNS) depressant drugs

Design outcomes

Primary

Measure	Time frame
To compare the effect of intranasal dexmedetomidine and intranasal midazolam paediatric dental patients undergoing pulp therapies and extractionTimepoint: preoperative, 5 minutes after application and postoperative	—

Secondary

Measure	Time frame
To evaluate & compare the rate of acceptance & side effects of intranasal sedative agents.Timepoint: Preoperative 5 minutes after application & postoperative	—

Countries

India

Contacts

Public ContactDR PRAVEEN KUMAR N H

Department of Pedodontics

raghavendrahavale@gmail.com9448407300

Outcome results