A post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) / Paracetamol (325 mg) / Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery
- Conditions
- Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified
- Registration Number
- CTRI/2022/01/039531
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and Female patients of age 18-45 years (both inclusive).
2. Patients needing extraction for impacted third molars under local anaesthesia.
3. Patients having moderate to severe pain at baseline (once surgery is over and local anaesthetic effect has subsided).
4. Patients in general good health- American Society of Anaesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of outpatient conscious sedation).
5. Patients willing to give written informed consent and comply with the study procedure
1. Patients with known hypersensitivity to any of the study drugs.
2. Patients with any contraindication to the study drugs.
3. Patients who are pregnant or nursing.
4. Patients with history of peptic ulcers and/or GI bleeding.
5. Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery).
6. Patients developing any complication during or after surgery. Unusual surgical difficulty.
7. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 8. Patients with continuing history of alcohol and/or drug abuse. 9. Participation in another clinical trial in the past 1 month prior to screening. 10. Any other reason for which the investigator feels that patient should not participate.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sum of pain intensity difference in 6 hours (SPID6)Timepoint: Sum of pain intensity difference in 6 hours (SPID6)
- Secondary Outcome Measures
Name Time Method 1. Total pain relief in 6 hours (TOTPAR6) <br/ ><br>2. Time to onset of analgesia <br/ ><br>3. Time to Maximum pain relief (tMaxPR) <br/ ><br>4. Pain relief at 48 and 96 hours (PR48 and PR96) <br/ ><br>5. Change in swelling from baseline to end of the study <br/ ><br>6. Requirement of rescue analgesia during the study period <br/ ><br>7. Overall efficacy at end of studyTimepoint: 6 days