Study to compare a drug named Dexmedetomidine which will be given in nose and a syrup named triclofos sodium which will be given per mouth in children as prior medicine before CT Scan

Comparative Study of intranasal Dexmedetomidine Versus oral Triclofos Sodium as premedicant in Children undergoing Computed Tomography Imaging : A Parallel Group Single Blind Randomised Controlled Trial.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020243

Enrollment

Registered

2019-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Comparative Study of intranasal Dexmedetomidine Versus oral Triclofos Sodium as premedicant in Children undergoing Computed Tomography Imaging: children aged between 1 to 6 years with A

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children between 1 to 6 years of age. 2. ASA I/II 3. Children who are not well adapted for undergoing CT imaging .

Exclusion criteria

Exclusion criteria: 1) Known allergy or hypersensitivity reaction to Dexmedetomidine or Triclofos Sodium ;EMLA cream; and propofol. 2) Patients taking any other sedatives. 3) Patients with nasal infection & nasal pathology for intranasal route. 4) Patients with any significant cardiac or respiratory disease. 5) Patients with severe mental Retardation or gross neurodevelopmental disorder. 6) Patients with severe systemic diseases. 7)Refusal from parents to undergo study

Design outcomes

Primary

Measure	Time frame
Two Groups will be compared in terms of time required to attain successful sedation level as per MOAA/S scale between 0 and 3Timepoint: From 5 minutes prior to Drug administration to 1 hour after imaging study	—

Secondary

Measure	Time frame
Both the groups will be compared in terms of 1.Recovery from Successful sedation as per Modified Observerâ??s assessment of alertness / sedation scale 2.Ease of child parent separation.[10] 3.Tolerance to drugs. 4.Anaesthesiologist satisfaction. 5.Haemodynamic changes and adverse effects. 6. Radiologist Satisfaction .Timepoint: From 5 minutes prior to Drug administration to 1 hour after imaging study.	—

Measure

Time frame

Both the groups will be compared in terms of 1.Recovery from Successful sedation as per Modified Observerâ??s assessment of alertness / sedation scale 2.Ease of child parent separation.[10] 3.Tolerance to drugs. 4.Anaesthesiologist satisfaction. 5.Haemodynamic changes and adverse effects. 6. Radiologist Satisfaction .Timepoint: From 5 minutes prior to Drug administration to 1 hour after imaging study.

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Countries

India

Contacts

Public ContactPROF AMITA PAHARI

INSTITUTE OF POST GRADUATE MEDICAL EDUCATION &RESEARCH

dr.amitaacharya@yahoo.com9831650768

Outcome results

None listed

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