Health Condition 1: null- Dental pain following tooth extraction
Conditions
Interventions
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
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1.Surgical Time in excess of 45 minutes 2.Patients with known hypersensitivity to any of the study drugs 3.Patients with any contraindications to the study drugs 4.Patients who are pregnant or nursing 5.Patients with history of peptic ulcers and/or GI bleeding 6.Patients who have significant psychiatric history 7.Patients with severe kidney/ liver disease 8.Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; warfarin or other anti- coagulants 9.Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery) 10.Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation; 11. Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of analgesia, Time to Maximum Pain relief (tMaxPR), Pain relief at 8 hrs (PR8)Timepoint: After administration of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Troikaa Pharmaceuticals Limited
Outcome results
None listed