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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.
Phase 4 trial testing Oral tablet and transdermal patch in Pain, Postoperative in 108 participants. Status unknown.
15 January 2024
Quick facts
| Lead sponsor | B.P. Koirala Institute of Health Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 10 August 2023 |
| Primary completion | 15 January 2024 |
| Estimated completion | 15 January 2024 |
| Sites | 1 location across Nepal |
Drugs / interventions tested
- Oral tablet and transdermal patch — full drug profile →
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
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):
-
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:
- PubMed search for NCT06146491
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06146491 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by B.P. Koirala Institute of Health Sciences
- Last refreshed: 24 November 2023
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.
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