| CTRI Number |
CTRI/2024/02/062606 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the effectiveness of topical EMLA cream in reducing pain during intravenous cannulation by applying over skin in children between age groups 3 years to 12 years and measuring pain using various pain scales |
|
Scientific Title of Study
|
Efficacy of eutectic mixture of local anaesthetic cream to reduce intravenous cannulation pain in children - A randomized control 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 |
THAMIZSELVAN G |
| Designation |
Post graduate Junior resident |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Room number 49, paediatrics OPD, Department of paediatrics, Sri manakula vinayagar medical College and hospital, kalitheerthalkuppam, Madagadipet, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9789565777 |
| Fax |
|
| Email |
tamizhslvn1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KANIMOZHI T |
| Designation |
Associate professor |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Room number 48, paediatrics OPD, Department of paediatrics, Sri manakula vinayagar medical College and hospital, kalitheerthalkuppam, Madagadipet, Puducherry
Pondicherry
PONDICHERRY
605 107
India |
| Phone |
9952262500 |
| Fax |
|
| Email |
drkani88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
THAMIZSELVAN G |
| Designation |
Post graduate Junior resident |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Room number 49, paediatrics OPD, Department of paediatrics, Sri manakula vinayagar medical College and hospital, kalitheerthalkuppam, Madagadipet, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9789565777 |
| Fax |
|
| Email |
tamizhslvn1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical College and hospital , Puducherry |
|
|
Primary Sponsor
|
| Name |
THAMIZSELVAN G |
| Address |
Room number 49, paediatrics OPD, Department of paediatrics, Sri manakula vinayagar medical College and hospital, kalitheerthalkuppam, Madagadipet, Puducherry - 605107 |
| Type of Sponsor |
Other [Sponsored by Principal investigator ] |
|
|
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 |
| THAMIZSELVAN |
Sri manakula vinayagar medical College and hospital |
Room number 49 and 308, paediatric ward,department of paediatrics
Pondicherry
PONDICHERRY |
9789565777
tamizhslvn1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH - ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cetaphil moisturizer cream (placebo) |
Cetaphil moisturizer cream used as comparator agent.It looks similar in color and texture as Eutectic mixture of local anaesthetic cream and used as placebo in this study. It is applied only once over dorsum of non-dominant hand of size 3x3cm (approximately 1.5gram) over 30 minutes |
| Intervention |
Eutectic mixture of local anaesthetic cream (2.5% lignocaine and 2.5% prilocaine) |
To assess the efficacy of Eutectic mixture of local anaesthetic cream to reduce intravenous cannulation pain in children. After explaining the procedure to participants an EMLA cream will be applied only one time over dorsum of non-dominant hand of 3x3 cm size, approximately 1.5 grams with occlusive dressing. After a specific time period to which participant randomized occlusive dressing will be removed, after cleaning with spirit, iv cannulation will be performed by staff nurse or other person trained in iv cannulation. The principal investigator will assess the efficacy of EMLA cream in reducing iv cannulation pain using various pain scale according to age group and also to study the time of application for reducing iv cannulation pain. |
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between age groups 3 years to 12 years requiring non-emergent Intravenous cannulation
2.Parents who are willing to participate in the study and giving informed written consent
|
|
| ExclusionCriteria |
| Details |
1.Emergency situations requiring immediate intravenous access
2.History of atopy
3.Open wounds or rash on dorsum of hand
4.Hypersensitivity to Eutectic mixture of local anaesthetic cream
5.Facial anomalies( preventing typical facial expressions of pain )
6.Cognitive dysfunction and conditions affecting ability to rate pain
7.Local erythema or blanching following eutectic mixture of local anaesthetic cream application
8.Requiring more than one attempt for cannulation
9.Children with poorly visible veins
10.Parents not willing to participate and give consent for study
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intravenous cannulation pain using eutectic mixture of local anaesthetic cream using visual analog scale pain score and FLACC scale and 4 point pain scale |
Outcome (reduction in intravenous cannulation pain assessed using pain scales) will be assessed at specific time based on group which participants randomized. For Group A - assessed after 30 minutes application of placebo
Group B - assessed after 30 minutes application of EMLA
Group C - assessed after 60 minutes application of EMLA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the timing of application of topical EMLA cream for intravenous cannulation in children |
30 minutes and 60 minutes application time |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized controlled double blinded study will be conducted in the Department of Paediatrics, Sri Manakula Vinayagar Medical College And Hospital (SMVMCH) a tertiary care hospital in Puducherry after the approval of Research Committee and Institutional Ethics Committee. Any child from 3-12 years of age satisfying selection criteria will be recruited in the study after obtaining written informed consent from parents of all participants and oral assent for children above 7 years.
Sequentially numbered Sealed Opaque envelopes will be opened by Post Graduate or Intern and the child will be allotted to the respective intervention group as per the block randomized list. Baseline sociodemographic details including anthropometry, indication of cannulation, site and size of cannula will be recorded in proforma.
After explaining the procedure, non-dominant hand(unless otherwise specified) will be chosen and a suitable vein on the dorsum of the hand will be selected. Consequently 1.5 gram of placebo(CETAPHIL MOISTURIZER LOTION ) with same color as EMLA cream for Group A and 1.5gram of EMLA cream ( PRILOX CREAM )for Group B and Group C will be taken in gauze and applied in 3x3 cm size with an occlusive dressing by same Post Graduate or Intern blinding the child parents to the group .
The occlusive dressing will be removed after 30 minutes in Group A and Group B and after 60 minutes for Group C. The area will be wiped dry with gauze and observed for signs of any local reactions. After disinfecting the site with spirit, intravenous cannulation will be performed with 24 gauge or 22 gauge IV cannula by staff nurse.
A Principal Investigator blinded to interventions will ask the participants between age groups 7 to 12 years to rate the pain they felt during cannulation on a standard 100mm visual analogue scale from 0 = no pain to 100 = worst possible pain. Children aged 3 to 7 years will be observed and scored for pain behaviors by Principal Investigator during intravenous cannulation by using the Face, Leg, Activity, Cry and Consolability (FLACC) behavioral Pain scale coded as mild(0-3),moderate(4-6) and severe(7-10). The assessor also rates the pain using 4 point scale with 0 being no response, 1 mild facial grimace, 2 verbal response and 3 withdrawal of hand. Since assessment of pain is our primary objective we have used multiple scales that are age appropriate, both subjective and objective scales to minimize bias.
Heart rate and blood pressure will be recorded before and immediately after cannulation.
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