A randomized open label comparative study evaluating the efficacy and tolerability of diclofenac (50mg) + paracetamol (500mg) FDC vs. ibuprofen (400mg) in the management of dental pain following impacted third molar extraction

Troikaa Pharmaceuticals Limited0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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).

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