| CTRI Number |
CTRI/2024/04/065585 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study Between Diclofenac And Ketoprofen Transdermal Patch For Pain Management In Patients Undergoing Minor Oral Surgical Procedures |
|
Scientific Title of Study
|
Comparison Between Efficacy Of Transdermal Diclofenac And Ketoprofen Patch For Pain Management In Patients Undergoing Minor Oral Surgical Procedures. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amir Sohail |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room Number 2B, Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore.
Bangalore KARNATAKA 560002 India |
| Phone |
7204678825 |
| Fax |
|
| Email |
mdamirsohail44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hemamythily P |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room Number 2B,Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore.
Bangalore KARNATAKA 560002 India |
| Phone |
8618429628 |
| Fax |
|
| Email |
h_mythily@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Girish B Giraddi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room Number 2B, Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute Bangalore.
Bangalore KARNATAKA 560002 India |
| Phone |
9740098199 |
| Fax |
|
| Email |
girishgiraddi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Research Institute, Victoria Hospital Campus, K R Market, Bangalore, Karnataka, India 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Amir Sohail |
| Address |
Dept of OMFS, Government Dental College and Research Institute, Bangalore |
| 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 Amir sohail |
Government Dental College and Research Institute, K R Market, Bangalore |
Room Number 2B, Department Of Oral And Maxillofacial Surgery Bangalore KARNATAKA |
7204678825
mdamirsohail44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Dental College And Research Institute, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Aceclofenac+Paracetamol |
Aceclofenac 100mg +
Paracetamol 325mg
Orally, Twice A Day After Food For 5 Days |
| Comparator Agent |
Transdermal Diclofenac Patch |
Patch Containing Diclofenac 100mg, To be Applied Transdermally, Once Daily for One Day Post Operatively. |
| Comparator Agent |
Transdermal Ketoprofen Patch |
Patch Containing Ketoprofen 30mg, To be Applied Transdermally, Once Daily for One Day Post Operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 Category Patients
Transalveolar Extractions
Alveoloplasty Procedures
Enuleation Procedures
Soft Tissue Biopsies |
|
| ExclusionCriteria |
| Details |
Subjects Allergic To Diclofenac, Ketoprofen Or Any Other NSAIDs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain measurement using Visual analogue scale and Wong Bakers scale |
pain measurement using Visual analogue scale and Wong Bakers scale at 0,6,12,24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating The Efficacy Of Trandsdermal Diclofenac And Ketoprofen Patch In Pain Management Using Visual Analogue Scale And Wong Bakers Scale |
Pain Measurement At The Interval Of 0,6,12,24,48 Hours |
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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 3 |
|
Date of First Enrollment (India)
|
24/04/2024 |
| 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="1" |
|
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
|
Post operative pain control is a significant aspect in patient management following an oral and maxillofacial surgical procedure. A clinician’s inadequacy in providing adequate analgesia to relieve post operative pain may lead to patient’s physical as well as psychological stress in the post surgical recovery. Pain can be managed by pharmacological methods. Hence post operative pain management heavily relies on pharmacological methods. There are both opioid and non opioid drugs for the management of pain, although opioids are potent analgesics its dependency makes non opioid a better option for pain management. NSAIDS are the most commonly used non opioids, and use of them have advantages of adequate pain control, but has its own disadvantages. Management of post operative pain remains an area for never ending research with newer modalities constantly emerging and outnumbering the obsolete ones. One such upcoming modality is transdermal patch, which provides sustained release of drug through cutaneous route into the bloodstream. Previously done studies have shown that transdermal patch are effective in the management of mild to moderate pain especially in patients with gastric problems and for better compliance, and Diclofenac and ketoprofen are the most commonly used NSAIDs as transdermal patches owing to their potency in pain management. However there exists a lacunae regarding the application of transdermal patches in the field of oral and maxillofacial surgery. |