To compare the efficacy and safety of two different analgesic formulations in the management of pain following extraction of the wisdom teeth that donot erupt properly from both the sides.
- Conditions
- Health Condition 1: null- Patients needing bilateral impacted third molar tooth extraction
- Registration Number
- CTRI/2011/08/001966
- Lead Sponsor
- Troikaa Pharmaceuticals limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1 Patients needing bilateral tooth extraction for impacted third molar under local anesthesia
2 Patients between the ages of 18 to 65 years
3 Patients with in general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration in out-patient of conscious sedation)
4 Patients willing to undergo observation period for four hours post-extraction
5 Patients willing for telephonic follow up
6 Patients with ability to complete a 10 cm visual analog scale(VAS)
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 Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery)
10 Patients developing any complication during or after surgery
11 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
12 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 the first dose of medication. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Pain intensity difference at 8 hours (PID8) <br/ ><br>Time to maximum Pain Intensity Difference(tmaxPID) <br/ ><br>Pain relief scores at 24, 48, 72 hours (PR24, PR48 , PR72 ) <br/ ><br>Global efficacy by patients and investigator <br/ ><br>Rescue analgesia requirementTimepoint: The pain intensity shall be assessed at baseline, 30min, 60 min, 2hr, 4 hr, 6 hr, 8 hr, 24hr, 48hr and on the 4th post extraction day.