Comparative evaluation of transdermal diclofenac and oral diclofenac in management of post operative pain in bilateral extractions an in vivo study

Transdermal Drug delivery System offers various advantages like delivering drug painlessly and directly into the systemic circulation at a constant rate, minizing the Gastro intestinal side effects, possibility to terminate the delivery of drug abruptly. This study aims at comparing the efficacy of transdermal diclofenac diethylamine 100mg (dicloPLAST 100mg) with Oral Diclofenac soduium 50mg (Fenac 50) in post operative pain management in bilateral extractions.

After proper case recording and selecting the patients based on inclusion and exclusion criterea, the procedure is thoroughly explained to the patient about the use of transdermal diclofenac patch as an alternative for oral diclofenac tablets. Patient is asked to take the preoperative diclofenac sodium 50mg tab one hour before the procedure. In Under aseptic precautions, armamentaria are prepared for extraction. Of the two teeth to be extracted in two quadrants, extraction of one tooth is performed under local anesthesia 2% with adrenaline 1:80000 (Lignox 2%) with tablet diclofenac 50mg one hour before procedure. Tablet diclofenac sodium 50mg (FENAC 50 - Ortin laboratories) tds for three days, Tablet Ranitidine 150mg (Rantac 150 - JB chemicals and Pharmacueticals Pvt Ltd) bid for three daysand Capsule amoxicillin 500 mg (Mox 500 – Ranbaxy laboratories) tds for five daysif neededare prescribed. Tablet Paracetamol 500mg (Dolo 500 - Micro labs Pvt Ltd) ten in numbergiven to the patients as a rescue medication which can be taken in case of increase in pain. Patients are assigned to score the post operative pain three times in a three consecutive days in VAS – Visual analog scale, VRS – Verbal response scale, PIS- Pain intensity scale , PRS – pain relief scale after 2 hours, 6 hours and 12 hours and to stop the scoring there after if they required the tab paracetamol 500 for pain relief and from there number of paracetamol tablet is calculated.

Patient is recalled for the next extraction one week for the next extraction. Patient is instructed to apply the diclofenac diethyleamine 100mg patch (dicloPLAST 100mg) over right upper arm two hour beforeprocedure and the extraction of tooth in opposite side of the jaw is carried out under under local anesthesia 2% with adrenaline 1:80000 (Lignox 2%). Capsule Amoxicillin 500 mg (Mox 500) tds for five daysis prescribed to the patient if needed. Patient is asked to change the patch and exactly 24 hours once exactly from the time of application for three days. Tablet Paracetamol 500mg (DOLO 500) ten in number are given to the patients as a rescue medication which can be taken in case of increase in pain. Patients are assigned to score the post operative pain three times in a three consecutive days as previously done and to and to stop the scoring there after if they required the tab paracetamol 500 for pain relief and from there number of paracetamol tablet is calculated.The null hypothesis is there is no difference in efficacy of Trandermal Diclofenac diethylemaine 100mg patch and Oral Diclofenac sodium 50mg in post operative pain management in bilateral extractions.