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.

Name: Clinical Trial NCT06146491
Creator: B.P. Koirala Institute of Health Sciences
Keywords: Pain, Postoperative, Oral tablet and transdermal patch, Phase 4, drug, clinical trial, Nepal

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

B.P. Koirala Institute of Health Sciences·Phase 4·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Pain, Postoperative
Drug/Device/Intervention: Oral tablet and transdermal patch
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: B.P. Koirala Institute of Health Sciences
Location: Dharān Bāzār, Nepal

Timeline & enrollment

Phase: Phase 4
Start date: Aug 10, 2023
End date: Jan 15, 2024
Enrollment: 108 participants

Primary outcome

To compare the analgesic effectiveness of diclofenac trans dermal patch (200mg) and oral combination of paracetamol (500mg) and ibuprofen (400mg) following surgical removal of mandibular third molar.

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.

ICD-10 classifications

During surgical operationDuring surgical operationDuring surgical operationPain, unspecifiedPostoperative intestinal obstruction

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06146491
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06146491 through Pure Global AI's free database. This Phase 4 trial is sponsored by B.P. Koirala Institute of Health Sciences and is currently Recruiting. The study focuses on Pain, Postoperative. Target enrollment is 108 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.