| CTRI Number |
CTRI/2024/07/070481 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of one spray versus two sprays of ethyl chloride to reduce venepuncture induced pain |
|
Scientific Title of Study
|
A Randomised Study to Compare the Effectiveness of One Spray versus Two Sprays of Ethyl Chloride of Reducing Venepuncture Induced Pain in Patients requiring IV Cannulation Before Surgery under Anaesthesia at SMS Medical College, Jaipur |
| 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 Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
Sawai man Singh medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanvantari building SMS Medical College, Jaipur
Jaipur
Rajasthan
India
Jaipur
RAJASTHAN
302001
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
Sawai man Singh medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanvantari building SMS Medical College, Jaipur
Jaipur
Rajasthan
India
Jaipur
RAJASTHAN
302001
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ragini |
| Designation |
Junior Resident |
| Affiliation |
Sawai man Singh medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanvantari building SMS Medical College, Jaipur
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302001
India |
| Phone |
9466226010 |
| Fax |
|
| Email |
raginisk2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, second floor, Dhanvantari building, SMS Medical College, Jaipur, Rajasthan, India
302001 |
|
|
Primary Sponsor
|
| Name |
Sawai man Singh medical College |
| Address |
Department of Anaesthesia, Second floor, Dhanvantari building, SMS Medical College and Hospital, Jaipur
Jaipur Rajasthan India
302001 |
| 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 Ragini |
Sms medical College and Hospital |
Ot-2 complex ,room number 229, second floor,Department of Anaesthesia, SMS Medical College
Jaipur
RAJASTHAN |
9466226010
raginisk2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee, SMS Medical College and attached hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ethyl chloride spray |
25 gauge cannula will be put on forearm after two sprays of ethyl chloride each for 5 seconds at a distance of 5 centimeters perpendicular to the skin surface |
| Intervention |
venepuncture |
25 gauge cannula will be put on forearm after using one spray of ethyl chloride for 5 seconds at a distance of 5 centimeters perpendicular to the skin surface |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.) Patients requiring IV Cannulation Before Surgery under Anaesthesia
2.) Patients giving written and informed consent
3.)Age :18-60 years
4.)of either sex |
|
| ExclusionCriteria |
| Details |
1.) Patient who is part of any other study
2.) Uncooperative patients
3.) Skin allergy
4.) Requiring more than one venepuncture attempt |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the venepuncture induced pain after Ethyl Chloride spray using VAS score |
To assess the venepuncture induced pain after Ethyl Chloride spray using VAS score immediately,at 3 minutes and at 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess & compare proportion of cases with side effects like rash , cutaneous flushing etc |
Incidence of side effects like rash, cutaneous flushing etc are noted till 1 hour of application of ethyl chloride |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="10"
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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Study Protocol
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 22-01-2025 and end date provided 26-06-2030?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients requiring IV Cannulation before surgery under anaesthesia satisfying the inclusion criteria will be included.NBM status,PAC,and consent will be checked and routine monitors will be attached. Following the ethyl chloride spray venepuncture will be done on the forearm using 25 gauge cannula. Patients in first group will receive one spray of ethyl chloride for 5 seconds perpendicular to the skin from a distance of 5cm.and patients of second group will receive spray of ethyl chloride twice each over 5 seconds perpendicular to the skin.All patients will report the procedure related pain following VAS score.Pain analysis will be done immediately,at 3 Minutes and at 5 minutes |