Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine in Children aged 5 to 14 years for Procedural Sedation

A Randomised Control Trial comparing the Efficacy and Safety of Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine for Procedural Sedation in children aged 5-14 years.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099174

Enrollment

180

Registered

2025-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Atomised intranasal Dexmedetomidine: Dexmedetomidine 2mcg/kg/dose will be given through intranasal route in Atomised form 30 minutes prior to painful procedures Control Intervention1: I

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 5 -14 years having ASA physical status 1 and 2 as per ASA guidelines

Exclusion criteria

Exclusion criteria: 1-Any known allergy to drug 2- Children having Severe Liver or Renal Insufficiency 3- Severe bradycardia or atrioventricular block above II degree type 2 4- Children whose parents refuse to give consent

Design outcomes

Primary

Measure	Time frame
Depth of SedationTimepoint: 120 minutes or till clinical recovery.	—

Secondary

Measure	Time frame
Time of recovery from sedationTimepoint: 30,45,60,75,90,105,120 minutes	—

Countries

India

Contacts

Public ContactDr Bhaviya

bhaviyarm@gmail.com7206793118

Outcome results

None listed

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