drugset / Trial / NCT06146491

A COMPARISON OF TRANSDERMAL DICLOFENAC AND ORAL COMBINATION OF PARACETAMOL AND IBUPROFEN IN POSTOPERATIVE PAIN MANAGEMENT FOLLOWING SURGICAL EXTRACTION OF MANDIBULAR THIRD MOLAR- A RANDOMISD CONTROLLED TRIALS.

NCT06146491

Phase 4 Unknown 108 enrolled B.P. Koirala Institute of Health Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2023-08-10
Primary completion
2024-01-15
Completion
2024-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg Oral
Comparator Diclofenac Other / unclassified 200 mg Other
Comparator Ibuprofen Small molecule 400 mg Oral

Indications

No indication recorded.