Transdermaal patches for pain relief following Oral surgery

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/09/036381
• Lead Sponsor: NITHISH SANKEPALLY

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-09
• Study Start: 2021-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Both Male and Female Patients undergoing orthognathic surgery and willing or giving consent for surgery.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain assessment following surgery using visual analogue scale	2hrs, 6hrs,12hrs, 18hrs ,24 hrs following surgery

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SRM DENTAL COLLEGE, BHARATI SALAI, CHENNAI, TAMIL NADU - 600089; 🇮🇳 Chennai, TAMIL NADU, India

SRM DENTAL COLLEGE, BHARATI SALAI, CHENNAI, TAMIL NADU - 600089

🇮🇳Chennai, TAMIL NADU, India

Nithish Sankepally

Principal investigator

07349220735

nithish.1234@gmail.com