| CTRI Number |
CTRI/2025/09/094087 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing a numbing spray and a numbing cream to see which works better at reducing the pain while securing IV lines in children. |
|
Scientific Title of Study
|
Comparison of 10 percent Lidocaine Spray versus 2.5 percent Lidocaine and 2.5 percent Prilocaine i.e.EMLA Cream for Attenuating Pain from Peripheral Venous Cannulation in Children: A Prospective Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shenaz Banu |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex, 13 A,Pondy to Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital ,Ariyur, Puducherry. Pondicherry 605102
India
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9585440861 |
| Fax |
|
| Email |
shenazshinee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chinthavali Sujatha |
| Designation |
Associate professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex, 13 A,Pondy to Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital ,Ariyur, Puducherry. Pondicherry 605102
India
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shenaz Banu |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex, 13 A,Pondy to Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital ,Ariyur, Puducherry. Pondicherry 605102
India
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9585440861 |
| Fax |
|
| Email |
shenazshinee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shenaz Banu B |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, 13 A, Pondy-Villupuram Main Road, Ariyur, Puducherry, India, 605102 |
| 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 Shenaz Banu |
Sri Venkateshwara Medical College Hospital and research centre |
Department of Anaesthesiology, Main OT complex, 13 A,Pondy to Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital ,Ariyur, Puducherry. Pondicherry 605102
India
Pondicherry
PONDICHERRY |
9585440861
shenazshinee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A 10% Lignocaine Spray Group |
Group A 10 percentage Lignocaine Spray Group Patients in this group will receive three sprays ,total 30 mg of 10 percentage lignocaine at the intended venous cannulation site from a distance of 5 cm. The site will then be covered with a transparent occlusive dressing and left in place for 10 minutes prior to cannulation. |
| Comparator Agent |
Group B EMLA Cream Group |
Patients in this group will be receiving 1 to 2 gm of EMLA cream which will be used to attain a thick even layer of 2-3 mm height over an area of 10 cm 2 on the preselected targeted venous cannulation site. The area will be covered with a transparent occlusive dressing and left for 60 minutes prior to cannulation. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children between 5 and 14 years undergoing elective procedures requiring anaesthesia
American society of Anaesthesiologists (ASA) grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Children with difficult IV cannulation
Emergency surgeries with burns, broken or infected skin
Intellectual disabilities
BMI above 85th percentile
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain during intravenous cannulation . Visual analogue scale score measured at the time of cannulation
Hemodynamic parameters like heart rate and oxygen saturation is measured |
Pain score at the time of baseline - during the time of intravenous cannulation
and hemodynamic parameters measured five minutes before ,at the time of cannulation and five minutes after cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate changes before, during, after), ease of cannulation, and local side effects |
Twenty , forty and sixty minutes after the cannulation |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
12/09/2025 |
| 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="0"
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
|
This study compares 10 percent lidocaine spray with EMLA cream made of 2.5 percent lidocaine and 2.5 percent prilocaine for reducing pain during intravenous cannulation in children aged 5 to 14 years undergoing elective surgeries. A total of 126 children will be randomly divided into two equal groups. One group will receive lidocaine spray and the other will receive EMLA cream before cannulation. The primary outcome is pain score measured using the visual analogue scale during cannulation. Secondary outcomes include heart rate changes before during and after cannulation, ease of cannulation, and local site reactions such as redness swelling and hardening at 20, 40 and 60 minutes after cannulation. The purpose of the study is to find out which topical anesthetic provides faster onset, better safety and more effective pain relief for children undergoing intravenous cannulation. |