To compare 2 different methods of drug delivery for sedationin children undergoing MRI.

A comparison of atomizer and drop method for sedation with intranasal dexmedetomidine in children undergoing MRI. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066436

Enrollment

Registered

2024-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: Intranasal dexmedetomidine: Intranasal preservative-free dexmedetomidine in a concentration of 100 µg.ml-1 by the drop method (using a syringe) in a dose of 2 µg/kg Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patients in the age group of 6 months to 5 years with ASA physical status I-II undergoing MRI.

Exclusion criteria

Exclusion criteria: 1.Known allergy or hypersensitivity to dexmedetomidine. 2.Upper respiratory infections/nasal pathology.

Design outcomes

Primary

Measure	Time frame
A comparison of atomization and drop method using intranasal dexmedetomidine for sedation in children undergoing MRI with the Modified Ramsay Sedation Score for MRI in children. Timepoint: 45 minutes from administration of drug	—

Secondary

Measure	Time frame
To comapre the onset time and duration of sedation.Timepoint: from Modified Ramsay Seadtion Score of 5 to 1;To compare behavior score during administration of intranasal dexmedetomidine using Likert scale.Timepoint: At the time of administration of drug;To compare the haemodynamic effects.Timepoint: SpO2, HR and RR will be measured every 5 minutes and BP every 10 minutes;To compare the movement score during the procedure in both the groups.Timepoint: At the time when patient is undergoing MRI	—

Measure

Time frame

To comapre the onset time and duration of sedation.Timepoint: from Modified Ramsay Seadtion Score of 5 to 1;To compare behavior score during administration of intranasal dexmedetomidine using Likert scale.Timepoint: At the time of administration of drug;To compare the haemodynamic effects.Timepoint: SpO2, HR and RR will be measured every 5 minutes and BP every 10 minutes;To compare the movement score during the procedure in both the groups.Timepoint: At the time when patient is undergoing MRI

—

Countries

India

Contacts

Public ContactDr Ameeta Sahni

Vardhman Mahavir Medical College and Safdarjung Hospital

Ameetaas@yahoo.com9811201585

Outcome results

None listed

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