To compare the efficacy and safety of two different analgesic formulations in the management of pain following tooth extraction

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: Fixed Dose of Diclofenac 50 mg + Paracetamol 500 mg: one tablet Twice a Day Control Intervention1: Paracetamol 500 mg: One tablet Four times a Day CONDITION: Dental pain following tooth extraction PRIMARY OUTCOME: Time to onset of analgesia, ; Time to Maximum Pain relief (tMaxPR), ; Pain relief at 8 hrs (PR8)‐‐‐‐‐‐Timepoint: After administration of study medication SECONDARY OUTCOME: Pain intensity difference at 8 hours (PID8); ; Pain relief scores; ; Rescue analgesia requirement; ; Global efficacy by patients and investigator. ; ‐‐‐‐‐‐Timepoint: At 8 hours after study medication adminstartion; ; At 30, 60 minutes, 2, 4, 6, 8, 24, 48 hrs of giving the medication and on the 4th post extraction day; ; At 8, 48 hours and 4th post extraction day; ; At the end of study. ; ; INCLUSION CRITERIA: 1.Patients undergoing tooth extraction under local anesthesia. 2.Between the ages of 16 to 35 years 3.Willing to undergo observation period for four hours post‐extraction 4.Willing for telephonic follow up and at least 1 follow up visit. 5.Ability to complete a 10 cm visual analog scale and a category scale every 30 minutes for the first 4 post extraction hours
Epistemonikos ID: 2eeef7d6bc30cd5289a67dcb87a5398a882d0354
First added on: Aug 22, 2024