A COMPARISON OF ANALGESIC EFFICACY OF TRANSDERMAL DICLOFENAC AND ORAL COMBINATION OF PARACETAMOL AND IBUPROFEN IN POSTOPERATIVE PAIN MANAGEMENT FOLLOWING SURGICAL EXTRACTION OF MANDIBULAR THIRD MOLAR

IRC/2223/022

This is comparative interventional study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the Department of Oral and Maxillofacial surgery, College of Dental Surgery, BPKIHS, Nepal. Verbal and written will be taken . Participants meeting inclusion criteria will be included in the study and will be divided in to two groups, group A (Oral combination of paracetamol-500mg and ibuprofen -400mg) and group B ( Transdermal diclofenac patch-200mg) using computer generated randamization. Extraction will be carried out using standard protocol. Aformention drugs will given to participants accordingly for management of post operative pain.Tramadol will be given to each patient as rescue analgesics and allowed to have if pain score exceeds 7.post operative instruction will be given carefully. Rescue phone number will be provided in case of emergency. Telephonic interview will be performed at 12, 24 and 72 hours post operatively and pain score using numeric rating scale will be recorded.Any adverse effects of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS (Statistical Package for Social Sciences) for statistical analysis.

2023-08-10

2024-01-15

2024-01-15

Recruiting

Early phase I

108

Inclusion Criteria:Patients of ASA I and ASA II, who are consenting for the study. Patient indicated for surgical extraction of mandibular third molar - Exclusion Criteria:Hypersensitivity to local anesthetic agent Patient who are physically and mentally healthy Patient not consenting to participate in the study Pregnant females in their first and third trimester of pregnancy. Patients allergic to diclofenac and oral combination of Paracetamol and Ibuprofen. Patient taking any analgesic at the time of surgery. Patient on anticoagulant therapy. Patient under Corticosteroids therapy. Patient needing pre-operative antibiotics prophylaxis Patient having peptic ulcerative disease. Patient having acute localized infection like pericoronitis. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}

2023-11-24