| 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
|
|
|
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
|
|
|
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. |