FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078300 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to compare how well EMLA (Prilox) cream reduces pain when it is applied 1 hour before iv cannulation site in comparison to a placebo. 
Scientific Title of Study   A study to compare the efficacy of EMLA (Prilox) cream vs placebo application 1 hour prior to IV cannulation on procedural analgesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shah Vihar Pauravbhai 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, 2nd Floor, General ot Complex Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9426651039  
Fax    
Email  viharshah18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Chauhan 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, 2nd Floor, General ot Complex Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara GUJARAT 391760

Vadodara
GUJARAT
391760
India 
Phone  9099014672  
Fax    
Email  dr.dinesh77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Chauhan 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, 2nd Floor, General ot Complex Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara GUJARAT 391760


GUJARAT
391760
India 
Phone  9099014672  
Fax    
Email  dr.dinesh77@gmail.com  
 
Source of Monetary or Material Support  
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode 391760  
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen 
Address  Waghodia, Pipariya, Vadodara, Gujarat, India Pincode-391760 
Type of Sponsor  Private medical college 
 
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 Dinesh Chauhan  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  nd Floor, General OT Complex, Anaesthesia department, Dhiraj Hospital, Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodia, Pipariya, Vadodara , Gujarat 391760 Vadodara GUJARAT
Vadodara
GUJARAT 		 9099014672

dr.dinesh77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidhyapeeth Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA :
1) Patient willing to sign the written & informed consent.
2) Patients posted for elective surgeries.
3) Patients belonging to American Society of anesthesiologists grade I, Il amd III

 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1) Patients with known hypersensitivity to EMLA cream or any other local anesthetics.
2) Patients with methemoglobinemia or on drugs that may cause methemoglobinemia.
3) Patients with mental illness.
4) Patients with open wounds on dorsum of hand. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This observational study will help us to assess the efficacy of EMLA
(PRILOX) cream when compared to placebo application 1 hour prior to iv
cannulation.
 		 Baseline
60 minutes before intravenous cannulation 
 
Secondary Outcome  
Outcome  TimePoints 
This observational study will help us to assess the reduction in VAS score following application of EMLA
(PRILOX) cream v/s placebo application 1 hour prior to iv cannulation. 		 1 hour prior to iv cannulation. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/12/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  dr.dinesh77@gmail.com

  6. For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The purpose of the current study is to compare the efficacy of
EMLA (Prilox) cream to reduce pain while inertion of intravenous cannula in comparison to placebo application 1 hour prior on the basis of visual analog pain scale.
 
Close