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CTRI Number  CTRI/2024/07/069941 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   TO SEE HOW EFFECTIVELY TWO PAIN RELIEVING AGENTS ACT TO REDUCE PAIN WHILE SECURING CANNULA IN CHILDREN  
Scientific Title of Study   A COMPARATIVE STUDY OF EFFECTIVENESS OF VAPOCOOLANT SPRAY AND EMLA CREAM IN REDUCING PAIN DURING INTRAVENOUS CANNULATION IN PAEDIATRIC POPULATION 
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 PRIYANKA P V 
Designation  JUNIOR RESIDENT 
Affiliation  K. S HEGDE MEDICAL ACADEMY 
Address  K S HEGDE MEDICAL ACADEMY, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU, KARNATAKA
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU, KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9074981692  
Fax    
Email  priyankapv10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GAYATHRI BHAT 
Designation  PROFESSOR 
Affiliation  K S HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S Hegde Medical Academy, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU, KARNATAKA
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S Hegde Medical Academy, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU, KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448467181  
Fax    
Email  gaibhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PRIYANKA P V 
Designation  JUNIOR RESIDENT 
Affiliation  K S HEGDE MEDICAL ACADEMY 
Address  K S HEGDE MEDICAL ACADEMY, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S HEGDE MEDICAL ACADEMY, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU MANGALURU KARNATAKA
K S HEGDE MEDICAL ACADEMY, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S HEGDE MEDICAL ACADEMY, P.O NITYANANDAGAR, DERALAKATTE, MANGALURU MANGALURU KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9074981692  
Fax    
Email  priyankapv10@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S HEGDE MEDICAL ACADEMY, DERALAKATTE, P.O NITYANANDAGAR, MANGALURU, KARNATAKA 
 
Primary Sponsor  
Name  HAREESH BABU 
Address  PARAPRAVAN HOUSE, KEECHERY,ARALAM PO, KANNUR, KERALA, PIN: 670704  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PRIYANKA P V  K S HEGDE MEDICAL ACADEMY  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K S HEGDE MEDICAL ACADEMY, DERALAKATTE, P.O NITYANANDAGAR, MANGALURU
Dakshina Kannada
KARNATAKA 
9074981692

priyankapv10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, K S HEGDE MEDICAL ACADEMY  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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged between 6-18 years undergoing elective surgeries requiring intravenous cannulation 
 
ExclusionCriteria 
Details  1. Children undergoing emergency surgeries
2. Children with difficult cannulation
3. Children with failed cannulation in the designated site
4. Children with burns, broken or infected skin
5. Children with intellectual disabilities
6. History of allergy to local anaesthetics
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of vapocoolant spray and EMLA cream in terms of pain score using Wong-Baker faces pain rating scale  At 2 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of cannulation, hemodynamic changes, occurrence of adverse effects & cost analysis between two groups  1. Number of attempts- 0 minutes
2. Hemodynamic changes- At baseline, 2 minutes, 4 minutes, 8 minutes, 10 minutes
4. Occurrence of adverse effects such as erythema, edema, bruise, pallor, pruritus-
At 20 minutes, 40 minutes, 60 minutes
 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   14/07/2024 
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="1"
Months="5"
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  

Peripheral venous cannulation is one of the most common clinical interventions in health care system. This is a technique in which a cannula is placed inside a vein to provide direct access to circulating blood stream. Intravenous cannulation is a common painful procedure. No analgesics are routinely used. Needle related procedures induce anxiety, fear and distress especially in children. This could result in physiological, psychological, and emotional consequences such as increased pain sensitivity and inappropriate pain responses. Children may also show anticipatory anxiety which can generate physiological symptoms during needle related procedures, like vasovagal reactions, hypoxemia, tachycardia, and changes in hormonal levels. This can lead to needle phobia and even post-traumatic stress disorder. Therefore, the optimization of pain during these procedures is of pivotal importance in childhood.

 

For pain reduction, some methods have been suggested and studied, including the use of topical anesthetics such as lignocaine, distraction techniques, producing vibration in the tissue of the injection site, imposing pressure, thermotherapy, and cooling the injection site. Some effective pharmacological methods for reducing patient’s pain are topical anesthesia techniques, including gels, ointments, patches, and topical anesthetic sprays, which can reduce the pain caused by intravenous cannulation.

 

EMLA cream is a topical anesthetic combination of two amide group of local anesthetics, lignocaine 2.5% and prilocaine 2.5%. EMLA cream is a 5% oil and water-based admixture containing 25 mg/ml of lignocaine and 25 mg/ml of prilocaine. Maximum dose of EMLA is 8 mg/kg. EMLA cream is applied onto non-injured skin with an occlusive adhesive bandage.

The local anaesthetics accumulate near pain receptors of the skin, and the neuronal membranes are stabilized by changing the depolarization of cell membranes to sodium ions and blocks the conduction of nerve impulses and can provide analgesia in the superficial layers of the skin to a depth of 5 mm. But its prolonged duration for the onset of peak action, that is 60-90 minutes, reduces its feasibility to be used as a topical anaesthetic for pain reduction during intravenous cannulation, especially in emergency situation. After skin disinfection, one gram EMLA cream will be applied in a thick layer over a prominent vein on the dorsum of the hand with an occlusive dressing for 60 minutes. After 60 minutes, occlusive dressing will be removed and IV cannulation is attempted.

 

Vapocoolant spray contains ethyl chloride acts as a cryoanalgesic which can be used prior to intravenous cannulation to attenuate pain. After applying vapocoolant spray, the skin temperature falls by less than 10°C compared to the body temperature after a 10 seconds of application.

Vapocoolant spray temporarily and rapidly interrupt pain transmission by lowering the skin surface temperature, reducing the sensitivity of pain receptors, and interfering with ion channel valves in pain transmission, causing topical skin anesthesia. So this can be used as an alternative analgesic used to induce rapid anaesthesia during vascular access in emergency conditions. After skin disinfection, vapocoolant spray will be applied at a distance of 10 cm for 10-15 seconds. Liquid on the skin will be allowed to evaporate before performing I.V cannulation.

PURPOSE : is to compare the efficacy of vapocoolant spray and EMLA cream to reduce pain during intravenous cannulation in children.

 
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