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

Phase 4

Completed

Conditions: Health Condition 1: null- Dental Pain following tooth extraction

Registration Number: CTRI/2011/091/000169

Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1.Patients needing extraction for impacted third molars under local anesthesia. 2.Between the ages of 18 to 45 years. 3. In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation). 4.Willing to undergo observation period for three hours post-extraction. 5. Willing for telephonic follow up. 6. Ability to complete a 10 cm visual analog scale and a category scale every 30 minutes for the first 3 postoperative hours.

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 contraindication 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; coumarin or other blood thinners. 9. Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery). 10. Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomization. 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).