| 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
|
|
|
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
|
|
|
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. |