| CTRI Number |
CTRI/2025/12/098440 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Immediate and Delayed Application of Local Anaesthetics on pain reduction after IV cannulation |
|
Scientific Title of Study
|
A Comparative Analysis of Pain Reduction in IV Cannulation Between Immediate and Delayed Application of Lignocaine as Local Anaesthetics |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PURVI PATEL |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
3, Rajganga florence , karamsad vidhyanagar road, Karamsad
Pediatric department,H M Patel academic center, Shree krishna hospital, Gokalnagar
Anand
GUJARAT
388325
India |
| Phone |
09825661647 |
| Fax |
|
| Email |
evergreen.purvi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
HARDEE SHAH |
| Designation |
PG student |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09998063519 |
| Fax |
|
| Email |
hardeeshah21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARDEE SHAH |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09998063519 |
| Fax |
|
| Email |
hardeeshah21@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded,
Shree krishna hospital, Karamsad |
|
|
Primary Sponsor
|
| Name |
PURVI PATEL |
| Address |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad- 388325 |
| 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 Purvi Patel |
Shree krishna hospital |
Department of pediatrics, H M Patel academic center, gokalnagar, karamsad-388325
Anand
GUJARAT |
09825661647
evergreen.purvi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutionalethicscommi ttee2,Bhaikakauniversit y |
Approved |
| Institutionethicscommittee-2,Bhaikaka university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z139||Encounter for screening, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pain reduction after local anasthetist |
Assessment of pain reduction using pain assessment score during iv cannulation in patients receiving local anesthetic 30 minutes before the procedure |
| Intervention |
Pain reduction following local anaesthetist |
Assessment of pain reduction using pain assessment score during iv cannulation in patients receiving local anesthetic 5 minutes before the procedure
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range: Children aged 8 to 18 years old.
2. Consent: Written informed consent from parents or guardians and assent from children aged 7 and above.
3. Procedure: Children scheduled for elective intravenous cannula insertion as part of medical treatment or diagnostic procedures.
4. Health Status: ASA (American Society of Anesthesiologists) physical status classification I or II.
5. Previous Experience: Children with no previous negative experience with IV cannulation to avoid psychological biases.
6. Communication: Ability to understand and communicate pain levels using age-appropriate pain scales.
7. Stable Condition: Children who are in a stable medical condition and not in acute distress.
|
|
| ExclusionCriteria |
| Details |
1. Allergies: Known allergy or sensitivity to local anesthetics (e.g., lidocaine, prilocaine).
2. Skin Conditions: Presence of skin infections, dermatitis, or other skin conditions at the site of cannula insertion.
3. Medical Conditions: Children with chronic pain conditions or on regular pain medication.
4. Cooperation: Children who are unable to cooperate or follow instructions due to developmental delays, severe anxiety, or other behavioral disorders.
5. Recent Procedures: Children who have undergone IV cannulation within the past month to avoid sensitization or tolerance.
6. Weight: Extreme underweight or overweight children where standard dosing of local anesthetic may not apply appropriately.
7. Parental Refusal: Parents or guardians who refuse the use of local anesthetic for the procedure.
8. Language Barrier: Families unable to communicate effectively in the language used for the study without the aid of an interpreter.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of pain reduction after immediate and delayed application of local anesthetic during IV cannulation |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of pain relief after application of local anesthetic |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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 Yet Recruiting |
| 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
|
Pediatric patients often experience anxiety and pain during medical procedures, such as intravenous cannula insertion, which can lead to distress, decreased compliance, and potential procedural delays. Despite the prevalence of such procedures, there is limited evidence on the most effective pain management strategies, particularly the use of local anesthetics. This study aims to address this gap through a randomized trial evaluating the efficacy of local anesthetics in reducing post-insertion pain. Effective pain management can improve patient comfort, mitigate long-term psychological impacts like needle phobia, enhance procedural compliance, and optimize healthcare resource utilization. By advancing evidence-based practices, this research supports the ethical imperative of ensuring pediatric well-being and promoting patient-centered care. |