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CTRI Number  CTRI/2025/07/091087 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Do Adults Feel Less Pain During IV Insertion with EMLA Cream or Lidocaine Dressing? A Study to Compare Both Methods 
Scientific Title of Study   Comparison of pain perception during intravenous cannulation between EMLA cream and Lidocaine HCL padded dressing in adult patients: A prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sameeksha K Suvarna 
Designation  Post graduate student 
Affiliation  Yenepoya school of allied health sciences 
Address  Department of Anaesthesia and OT Technology Yenepoya School of Allied Health Sciences Dakshina Kannada KARNATAKA 575018 India
Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be university), Derlakatte Mangalore Dakshina Kannada 575018 India
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8971764325  
Fax    
Email  sameekshasuvarna27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nikin Thampi 
Designation  Assistant professor 
Affiliation  Yenepoya Medical College hospital 
Address  Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be university), Derlakatte Mangalore Dakshina Kannada 575018 India
Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be university), Derlakatte Mangalore Dakshina Kannada 575018 India
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9447744588  
Fax    
Email  drnikin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikin Thampi 
Designation  Assistant professor 
Affiliation  Yenepoya Medical College hospital 
Address  Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be university), Derlakatte Mangalore Dakshina Kannada 575018 India
Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be university), Derlakatte Mangalore Dakshina Kannada 575018 India
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9447744588  
Fax    
Email  drnikin@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya School of Allied Health Science, mudipu campus near Surya tech park kayaragoli, kurnad post bantwal 574153 
 
Primary Sponsor  
Name  Sameeksha K Suvarna 
Address  Yenepoya School of Allied Health Science, Mudipu campus near Surya tech park kayaragoli, kurnad post bantwal 574153 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikin Thampi  Yenepoya Medical college hospital Department of Anesthesiology Derlakatte   ward and pre-operative setting
Dakshina Kannada
KARNATAKA 
09447744588

drnikin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee-4  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients those who need intravenous cannulation under ASA Physical status 1 and 2 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  EMLA cream   Emla cream is a mixture of 2 local anesthetics lidocaine 2.5% and prilocaine 2.5%. These two ingredients work together to temporarily block nerve signals in the skin, providing effective surface numbness for medical or cosmetic procedures. 
Comparator Agent  Lidocaine HCL spray  Lidocaine HCL is a fast-acting local anesthetic that blocks nerve signals to reduce pain. It is used in spray, injections, creams or gels for minor procedure and can also treat irregular heartbeats. 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants of all gender aged between 19-60 years
2. Patients requiring intravenous cannulation
3. Only participants with American society of anesthesiologist physical status 1 and 2 are included
4. Patients undergoing elective surgery  
 
ExclusionCriteria 
Details  1. Patients who are unwilling or opposed
2. Coagulopathy or bleeding disorders
3. A history of allergic reactions to anesthetics 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the pain intensity experienced by adult patients during intravenous cannulation after application of EMLA Cream   done in ward and pre-operative setting applied and kept for 30 minutes and after cannulation pain scales are assesed 
 
Secondary Outcome  
Outcome  TimePoints 
o evaluate the pain intensity experienced by adult patients during intravenous cannulation after application of Lidocaine HCL  done in ward and pre-operative setting applied and kept for 30 minutes and after cannulation pain scales are assessed 
To compare the pain intensity experienced by adult during intravenous cannulation after application of either EMLA cream or Lidocaine HCL padded dressing   After cannulation and after taking VAS and VDS scale will compare takes less than 5 minutes 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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   N/A 
Date of First Enrollment (India)   28/07/2025 
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="11"
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  
This study is designed as a prospective observational study. The patient files will be used to
gather demographic information about the patients, such as age, gender. Vital indicators like
oxygen saturation (SpO2) and heart rate (HR) will be monitored during the procedure.
Following IVC, patients in both groups will use the Visual Analog Scale (VAS) and the Verbal
Descriptor Scale (VDS) to rate their level of discomfort. Two subgroups will be created from
the patients using EMLA CREAM and Lidocaine HCL during IVC- a routine procedure done
on the dorsum of the hand (Cephalic vein, basilic vein, dorsal metacarpal vein), will be carried
out by same anaesthesiologist, in the ward and pre-operative settings, each containing 57
participants.
In Group E (EMLA CREAM) the site where IVC is planned will be covered in padded dressing
impregnated with a thick layer of 1 mL (or 1 gram) of EMLA cream and left for 30 minutes.
After 30minutes the padded dressing will be removed and an effort will be made to perform
intravenous cannulation using a suitable gauged cannula by an experienced assigned
anaesthesiologist. In group L (Lidocaine HCL) a padded dressing impregnated with a 10%
lidocaine HCL pump spray solution will be applied to the skin where IVC is planned and left
in place for 30 minutes and cannulation is carried out by an anaesthesiologist while the
principal investigator will be observing and documenting the pain scores. The Visual Analogue
Scale (VAS) scores and VDS scores will be recorded, and hemodynamic parameters will be
monitored during the procedure. Assessing effectiveness typically involves standardized pain
measurement tools like the Verbal Descriptor Scale (VDS) and the Visual Analogue Scale
(VAS). The VDS allows patients to describe pain using terms such as "no pain" or "severe,"
while the VAS uses a 10-centimeter line to quantify pain intensity.
 
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