| CTRI Number |
CTRI/2021/09/036381 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Transdermaal patches for pain relief following Oral surgery |
|
Scientific Title of Study
|
DOES DIMETHYL SULFOXIDE(DMSO) ENHANCE TRANSDERMAL DICLOFENAC DRUG DELIVERY FOR POST OPERATIVE PAIN IN MAXILLOFACIAL SURGERY- A RANDOMISED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithish Sankepally |
| Designation |
Post graduate-trainee |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE,Bharathi salai, ramapuram, chennai-89
Bharathi salai, ramapuram, chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
7349220735 |
| Fax |
|
| Email |
nithish.1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gnanam A |
| Designation |
Professor |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE,Bharathi Salai, Ramapuram, Chennai-89
Bharathi Salai, Ramapuram, Chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
9841866379 |
| Fax |
|
| Email |
drgnanam@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nithish Sankepally |
| Designation |
Post graduate-trainee |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
SRM DENTAL COLLEGE,Bharathi salai, ramapuram, chennai-89
Bharathi salai, ramapuram, chennai-89
TAMIL NADU
600089
India |
| Phone |
7349220735 |
| Fax |
|
| Email |
nithish.1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM DENTAL COLLEGE,BHARATI SALAI, CHENNAI, TAMIL NADU-600089 |
|
|
Primary Sponsor
|
| Name |
NITHISH SANKEPALLY |
| Address |
SRM DENTAL COLLEGE, Ramapuram, Chennai-89 |
| Type of Sponsor |
Other [DENTAL COLLEGE- DEEMED TO BE] |
|
|
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 |
| Nithish Sankepally |
SRM DENTAL COLLEGE, BHARATI SALAI, CHENNAI, TAMIL NADU - 600089 |
Dept of ORAL AND MAXILLOFACIAL SURGERY, ground floor
Chennai
TAMIL NADU |
07349220735
nithish.1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DIMETHYLSULFOXIDE |
Three hour prior to the surgery,2ml of 60 % DMSO is applied over the non-hairy skin and let to dry for 20 min.following which a transdermal patch is placed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Both Male and Female Patients undergoing orthognathic surgery and willing or giving consent for surgery |
|
| ExclusionCriteria |
| Details |
Age group below 18 years and above 35 years
Patients not willing for surgery
Patients with known skin allergies.
Patients with allergies to diclofenac
Patients with systemic complications.
Patients with known hepatic and renal issues |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain assessment following surgery using visual analogue scale |
2hrs, 6hrs,12hrs, 18hrs ,24 hrs following surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The need to delay or decrease the need of rescue analgesic |
Based on Visual Analogue Scale, if patient score exceeds 5, a rescue analgesic is administered to ease post-operative pain. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/09/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nithish.1234@gmail.com].
- For how long will this data be available start date provided 01-12-2022 and end date provided 01-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Post-operative pain management following major surgeries play a key role in providing better ease to the patient. Transdermal patches are one of the methods of drug delivery system, efficacious for longer durations, they avoid the first-pass metabolism, but limitations such as poor diffusion into the skin because of the barrier mechanism which compromises their efficiency. DIMETHYL SULFOXIDE (DMSO) the organo-sulfur compound is a chemical permeation enhancer used to increase the permeation of skin. Hence the study hypothesizes to evaluate, if chemical permeation enhancers are effective in increasing the bioavailability of transdermal drug to achieve satisfactory post-operative analgesia |