Comparison of pain killer patch and Pain killer tablets in management of pain after bilateral teeth extractions
- Conditions
- post extraction pain management with transdermal diclofenac diethyleamine and oral diclofenac sodium.
- Registration Number
- CTRI/2018/01/011482
- Lead Sponsor
- Swaminathan
- Brief Summary
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 (Nupatch 100) 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 days**and **Capsule amoxicillin 500 mg (Mox 500 – Ranbaxy laboratories) tds for five days**if neededare prescribed. **Tablet** **Paracetamol 500mg (Dolo 500 - Micro labs Pvt Ltd) ten in number**given to the patients as a rescue medication which can be taken in case of increase in pain. Patient will be 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 (NU PATCH 100mg) over upper arm two hour before**procedure 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 days**is 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**were given to the patients as a rescue medication which can be taken in case of increase in pain. Patients will be 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
- Patient in the age group of 18-55 years will be selected irrespective of sex, caste, religion and socio-economic status.
- Bilaterally extraction of same teeth in adjacent quadrants of the jaw.
- Patients who agreed to follow the study protocol.
- Uncontrolled systemic diseases.
- Patient with anti-coagulant therapy.
- Patient allergic to diclofenac or any NSAIDS 4.
- Patient under medication of NSAIDS or corticosteroids for any other illness.
- Patient with history of peptic ulcer.
- Tender teeth and third molars and periodontally compromised teeth.
- Uncooperative patients not willing to commit to an appropriate post procedure follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analog scale (0-10) post operative pain score is evaluated in post operative 2 hours, 6 hours, 12 hours for three consecutive days.Scoring is stopped when the first emergency medication for pain tablet paracetamol 500mg is consumed by patient.There after number of tablet paracetamol 500mg consumed is calculated. post operative pain score evaluation in post operative pain score is evaluated in post operative 2 hours, 6 hours, 12 hours for three consecutive days.Scoring is stopped when the first emergency medication for pain tablet paracetamol 500mg is consumed by patient.There after number of tablet paracetamol 500mg consumed is calculated. Verbal rating scale (0-3) post operative pain score is evaluated in post operative 2 hours, 6 hours, 12 hours for three consecutive days.Scoring is stopped when the first emergency medication for pain tablet paracetamol 500mg is consumed by patient.There after number of tablet paracetamol 500mg consumed is calculated. Pain relief scale (0-3) post operative pain score is evaluated in post operative 2 hours, 6 hours, 12 hours for three consecutive days.Scoring is stopped when the first emergency medication for pain tablet paracetamol 500mg is consumed by patient.There after number of tablet paracetamol 500mg consumed is calculated. Pain intensity scale (0-3) post operative pain score is evaluated in post operative 2 hours, 6 hours, 12 hours for three consecutive days.Scoring is stopped when the first emergency medication for pain tablet paracetamol 500mg is consumed by patient.There after number of tablet paracetamol 500mg consumed is calculated.
- Secondary Outcome Measures
Name Time Method when patient start consuming emergency pain tablets paracetamol500mg, number of tablet paracetamol 500mg consumed is calculated.
Trial Locations
- Locations (1)
Sree Mookambika Institute of Dental Science
🇮🇳Kanniyakumari, TAMIL NADU, India
Sree Mookambika Institute of Dental Science🇮🇳Kanniyakumari, TAMIL NADU, IndiaDr C SwaminathanPrincipal investigator9444663867dr.swaminathan1990@gmail.com