| CTRI Number |
CTRI/2024/02/063393 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of pre-emptive analgesia on pain perception in pediatric dentistry. |
|
Scientific Title of Study
|
Effect of pre-emptive analgesia on pain perception in pediatric dentistry. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MIRA VIRDA |
| Designation |
Professor |
| Affiliation |
college of dental science and research centre, Ahmedabad |
| Address |
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
6351113441 |
| Fax |
|
| Email |
mirakataria14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MIRA VIRDA |
| Designation |
Professor |
| Affiliation |
college of dental science and research centre, Ahmedabad |
| Address |
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
6351113441 |
| Fax |
|
| Email |
mirakataria14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MIRA VIRDA |
| Designation |
Professor |
| Affiliation |
college of dental science and research centre, Ahmedabad |
| Address |
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
College Of dental sciences and research centre, Near Navneet Priting Press, Bopal, Manipur, Ahmedabad- 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
6351113441 |
| Fax |
|
| Email |
mirakataria14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics and Preventive Dentistry ,College Of Dental Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Mira virda |
| Address |
ColIege of dental science & research centre, Silver alaknanda dental college road, Nr Nvneet printing press,Opposite Pleasure club, Bopal,Manipur, Gujarat |
| 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 Mira virda |
COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE |
Department of Pediatrics and Preventive Dentistry, Room-9,College of dental science and research center Bopal Ahmedabad -382115
Ahmadabad
GUJARAT |
6351113441
mirakataria14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE BOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
B FOLCIN SYRUP |
B- FOLCIN SYRUP GIVEN 30 MINUTES PRIOR EXTRACTION |
| Intervention |
IBUPROFEN + PARACETAMOL |
IBUGESIC PLUS SYRUP GIVEN 30 MINUTES PRIOR EXTRACTION
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Co-Operative child,, either positive or definitely positive, according to FRANKLE behaviour rating scale and healthy child (ASA-1) according to the American society of aneshtsiologist classification.
The children who are not allergic to analgesics or local anesthesia.
The child age ranges between 7-10 years, and weight ranges between 22 to 30kgs (American academy of pediatric dentistry2020).
The molar selection criteria included those unfit for restoration or ones with abcess and infection exceeding 1/3 of the inter-radicular area.
|
|
| ExclusionCriteria |
| Details |
co-operative children
The children with history of prolonged bleeding, hypersensitivity or allergic reaction to analgesics
Molars which are not mobile and have more than 1/3 of root length and can be saved with restoration or pulp therapy.
Those children whose parents have not given concern. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to check the efficacy of preemptive drugs on pain perception of children |
PAIN LEVEL WAS ASSESSED USING WONG BAKER FACES PAIN RATING SCALE AFTER INJECTION EXTRACTION AND POST OPERATIVELY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
immediate post operative pain may be reduced and the development of chronic pain may be reduced
in achieving effective analgesia so to check the effect of preemptive drugs
on post operative pain following extraction |
after giving local anesthesia, post operatively and 2 hours after procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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="1"
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
|
The aim of the study is to assess the efficacy of pre-emptive analgesia on pain perception during local anesthesia administration and extraction in pediatric patient. Total 60 patients aged 7-10 years were selected who needed primary molar extraction. GROUP A Ibugesic plus syrup given 30 minutes prior extraction. GROUP B Placebo solution [ b- folcin syrup] given 30 minutes prior extraction. Pain level was assessed using wong baker faces pain rating scale after injection, extraction and post operatively. |