| CTRI Number |
CTRI/2019/07/020243 [Registered on: 18/07/2019] Trial Registered Prospectively |
| Last Modified On: |
12/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KABIR HOSSAIN |
| Designation |
POST GRADUATE TRAINEE DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION &RESEARCH |
| Address |
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
8584878222 |
| Fax |
|
| Email |
kabirhossain382@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF AMITA PAHARI |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION &RESEARCH |
| Address |
Department of Anesthesiology
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831650768 |
| Fax |
|
| Email |
dr.amitaacharya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF AMITA PAHARI |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION &RESEARCH |
| Address |
Department of Anesthesiology
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831650768 |
| Fax |
|
| Email |
dr.amitaacharya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology;IPGME&R; KOLKATA |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Medical Education Research |
| Address |
244 AJC BOSE ROAD;KOLKATA 700020;WEST BENGAL;INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KABIR HOSSAIN |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH |
244 AJC BOSE ROAD; KOLKATA 700020; DEPARTMENT OF ANAESTHESIOLOGY;BANGUR INSTITUTE OF NEUROLOGY,IMAGING DEPARTMENT,ROOM NO 2
Kolkata
WEST BENGAL |
8584878222
kabirhossain382@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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 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 10 min till 1 hour after imaging,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. |
| Intervention |
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 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 10 min till 1 hour after imaging,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.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 1 to 6 years of age.
2. ASA I/II
3. Children who are not well adapted for undergoing CT imaging . |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Two Groups will be compared in
terms of time required to attain
successful sedation level as per
MOAA/S scale between 0 and 3 |
From 5 minutes prior to Drug administration to 1 hour after imaging study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Both the groups will be compared in terms
of
1.Recovery from Successful sedation as per Modified Observer’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 . |
From 5 minutes prior to Drug administration to 1 hour after imaging study. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |