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

Phase 1

Not yet recruiting

• Conditions: Imaging,

• Registration Number: CTRI/2019/07/020243
• Lead Sponsor: Institute of Post Graduate Medical Education Research

Brief Summary

SUMMARY: Name of candidate/Designation/Place of posting : Dr. Kabir Hossain , 1 st Year Post Graduate  

Trainee, IPGME&R and SSKM Hospital, Kolkata.



Broad area and specific area- MD Anesthesiology, Session 2017-2020

Place of proposed research work and name of Institute/Department- Department of  

Anesthesiology, IPGME&R and SSKM Hospital, Kolkata.

Name of proposed supervisor: Prof ( Dr ) Amita Pahari; Professor  

, Department of Anesthesiology, IPGME&R and SSKM Hospital, Kolkata.

Name of proposed co-supervisor : Dr. Rajashree Biswas , Assistant Professor, Department of  

Anesthesiology, IPGME&R and SSKM Hospital, Kolkata.

Proposed topic of research- 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.

Objective of proposed research- Time required to attain successful sedation   level,recovery time from sedation,drug tolerance,haemodynamic changes,ease of child parent  

separation,Radiologist and Anaesthesiologist satisfaction.

Background of present study– Good quality of CT immaging children needs sufficient immobility   and anxiolysis. Various sedatives are used for this purpose and among them chloral hydrate derived   triclofos sodium is one of the widely used sedative in children for immaging study.But it has a pungent   odour with a bitter caustic taste and causes a high incidence of nausea and vomiting.Dexmedetomidine   is a highly selective a2-adrenergic receptor agonist with sedative and mild analgesic effects and it   has been increasingly used in paediatric non-invasive diagnostic procedures.It is easy to administer  

intranasally and it does not require IV access and it is generally well tolerated.

Methodology- children aged between 1 to 6 years with ASA physical status 1 or 2 scheduled   for CT immaging studies under sedation will be evaluated with history and physical   examination before inclusion and will be admitted to radiological suite at least 1 h prior to   imaging.. Oral drugs will be Aloe vera syrup as placebo and syrup Triclofos Sodium 100 mg/ml.   Intranasl drug will be saline or dexmedetomidine 100 mcg/ml. EMLA cream will be applied at   two preidentified venipuncture sites and sealed with occlusive dressing.For intranasal   administration, the drug will be dripped into child’s nostrils using a tuberculin syringe. In my   study before the CT immaging , children will drink 0.5 ml/kg. syrup and received 0.025 ml/kg   nasal drop. Blood pressure, pulse rate and oxygen saturation, Respiratory Rate will be   recorded before drug administration and then every 5 min,along with sedation (Modified   Observer’s assessment of alertness / sedation scale). After achieving IV access, children will  

be transferred to the CT table for imaging.

Expected outcome- Intranasal dexmedetomidine may yield better sedative effect and more acceptable,less   failure rate;smooth recovery,minimal adverse effect to children undergoing CT imaging in comparison with

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-15
• Last Update Posted: 2019-12-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children between 1 to 6 years of age.
• 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

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

Secondary Outcome Measures

Name	Time	Method
Both the groups will be compared in terms	of

Trial Locations

Locations (1)

INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH; 🇮🇳 Kolkata, WEST BENGAL, India

INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH

🇮🇳Kolkata, WEST BENGAL, India

DR KABIR HOSSAIN

Principal investigator

8584878222

kabirhossain382@gmail.com