| CTRI Number |
CTRI/2025/02/079838 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PERIPHERAL VEIN CANNULATION] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Peripheral venous cannulation in children using EMLA
or 10%Lidocaine spray. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF 10 PERCENT LIDOCAINE SPRAY VERSUS EUTECTIC MIXTURE OF 2.5 PERCENT LIDOCAINE AND 2.5 PERCENT PRILOCAINE (EMLA) TO ATTENUATE PAIN OF PERIPHERAL VENOUS CANNULATION IN CHILDREN
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NITHYA |
| Designation |
PG student |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
#120,BMCRI
Department of Anaesthesiology
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9500175571 |
| Fax |
|
| Email |
nithyarajagopal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheesh K |
| Designation |
Professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
BMCRI
Dept of Anaesthesiology
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
9900134694 |
| Fax |
|
| Email |
dr.sudhi77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya |
| Designation |
PG student |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
BMCRI
Dept of Anaesthesiology
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
9500175571 |
| Fax |
|
| Email |
nithyarajagopal1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANGALORE MEDICAL COLLEGE AND HOSPITAL
Bangalore
karnataka-560002
India. |
|
|
Primary Sponsor
|
| Name |
BANGALORE MEDICAL COLLEGE |
| Address |
DEPT OF ANESTHESIOLOGY
BMCRI
Bangalore
Karnataka -560002
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrNithya |
Victoria Hospital |
BMCRI
BANGALORE
560002
Karnataka
India
Bangalore
KARNATAKA |
9500175571
nithyarajagopal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% LIGNOCAINE SPRAY |
Peripheral vein cannulation in children
Duration of study -6months |
| Comparator Agent |
EMLA |
Peripheral vein cannulation in children
Duration of study - 6 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologist Class 1-2 (Annexure 3)
Aged 7-17 years undergoing elective surgical procedures requiring anaesthesia without
any peripheral IV access were enrolled
Informed consent from the parents and written assent from the participants. |
|
| ExclusionCriteria |
| Details |
Children with difficult IV cannulations, those undergoing emergency surgeries, with
burns, broken, or infected skin and with intellectual disabilities were excluded.7-17 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
compare the changes in heart rate,systolic blood pressure and Diastolic blood pressure at before
,during and after cannulation |
before cannulation
,during and after cannulation
20 min,40min,60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the VAS score among the two groups,
compare the ease of cannulation between two groups.
|
20min,40min,60min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Venepuncture and peripheral intravenous cannula insertions are the
two most common and painful procedures in hospitalized children .Minimizing pain and anxiety are not only imperative but also important for preventing long-term
behavioral problems and adverse clinical outcomes.this study is to compare the efficacy of 10% lignocaine spray versus EMLA cream in facilitating
analgesia for venous cannulation using the visual analogue scale (VAS) pain score . |