Last reviewed · How we verify

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.

Status unknown Phase 4 Last updated 24 November 2023
What this trial tests

Phase 4 trial testing Oral tablet and transdermal patch in Pain, Postoperative in 108 participants. Status unknown.

Timeline
10 August 2023
Primary endpoint
15 January 2024
15 January 2024

Quick facts

Lead sponsorB.P. Koirala Institute of Health Sciences
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment108
Start date10 August 2023
Primary completion15 January 2024
Estimated completion15 January 2024
Sites1 location across Nepal

Drugs / interventions tested

Conditions studied

Sponsor

B.P. Koirala Institute of Health Sciences

Who can join

18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Transdermal diclofenac versus oral paracetamol-ibuprofen combination for postoperative pain following surgical extraction of mandibular third molar: a randomized controlled trial.
    Khanal N, Jaisani MR, Dongol A, Acharya P, et al · · 2025 · PMID 41377332 · DOI 10.1097/ms9.0000000000004076

Verify or expand the search:

Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

Other B.P. Koirala Institute of Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06146491.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing