| CTRI Number |
CTRI/2024/11/077474 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Popsicles to Reduce Pain Perception in Children During Local Anesthesia A Comparative Study |
|
Scientific Title of Study
|
a comparative evaluation of pain perception in children with pre cooled injection sites using popsicles for local anaesthesia a 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 |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College
Chennai
Tamil nadu
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinic 28, Department of pediatric and preventive, saveetha dental college
Chennai
Tamil nadu
600077
India |
|
|
Primary Sponsor
|
| Name |
Harsh Sanjaykumar Baldawa |
| Address |
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India |
| 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 Deepa Gurunathan |
Saveetha Dental College amd Hospital |
Clinic 28, Department of Pediatric and
Preventive Dentistry, Saveetha Dental College and Hospital
Chennai
Tamil nadu
600077
India
Chennai
TAMIL NADU |
9994619386
deepag@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ice popsicles |
Precooled Popsicles is placed on the injection site for 1 minute and then local anaesthesia is administered |
| Comparator Agent |
topical anaesthetic spray |
Injection site is cleaned by cotton and then topical anaesthetic spray is applied on injection site. After 1 minute LA is administered |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.children age 4-9 years
2. frankles behavior rating scale 3 and 4
3. child with first dental visit
4. With no significant medical condition |
|
| ExclusionCriteria |
| Details |
1. frankles behavior rating scale 1 and 2
2. Frankles behavior rating scale 1 and 2
3. Medically compromised individuals
4. Parents who didnt give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anxiety |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
17/12/2024 |
| 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="0"
Months="0"
Days="10" |
|
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
|
in this randomised controlled trial, we aimed to compare pain perception in pediatric children during administration of local anaesthesia. This study investigates the impact of using popsicles to pre-cool injection sites on pain perception in children receiving local anesthesia. It will involve children, randomly assigned to either a popsicle group, where injection sites were pre-cooled with popsicles, or a control group with no pre-cooling. Pain perception will be measured using different Pain Rating Scale immediately after the injection. |