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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 Sca

Phase 1
Conditions
Health Condition 1: B- Imaging
Registration Number
CTRI/2019/07/020243
Lead Sponsor
Institute of Post Graduate Medical Education Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Two Groups will be compared in <br/ ><br>terms of time required to attain <br/ ><br>successful sedation level as per <br/ ><br>MOAA/S scale between 0 and 3Timepoint: From 5 minutes prior to Drug administration to 1 hour after imaging study
Secondary Outcome Measures
NameTimeMethod
Both the groups will be compared in terms <br/ ><br>of <br/ ><br>1.Recovery from Successful sedation as per Modified Observerâ??s assessment of alertness / sedation scale <br/ ><br>2.Ease of child parent separation.[10] <br/ ><br>3.Tolerance to drugs. <br/ ><br>4.Anaesthesiologist satisfaction. <br/ ><br>5.Haemodynamic changes and adverse <br/ ><br>effects. <br/ ><br>6. Radiologist Satisfaction .Timepoint: From 5 minutes prior to Drug administration to 1 hour after imaging study.
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