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

Phase 4

Completed

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

Registration Number: CTRI/2010/091/000099

Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to onset of analgesia, <br/ ><br>Time to Maximum Pain relief (tMaxPR), <br/ ><br>Pain relief at 8 hrs (PR8)Timepoint: After administration of study medication

Secondary Outcome Measures

Name	Time	Method
Pain intensity difference at 8 hours (PID8); <br/ ><br>Pain relief scores; <br/ ><br>Rescue analgesia requirement; <br/ ><br>Global efficacy by patients and investigator. <br/ ><br>Timepoint: At 8 hours after study medication adminstartion; <br/ ><br>At 30, 60 minutes, 2, 4, 6, 8, 24, 48 hrs of giving the medication and on the 4th post extraction day; <br/ ><br>At 8, 48 hours and 4th post extraction day; <br/ ><br>At the end of study. <br/ ><br> <br/ ><br>