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 | Unknown Phase 4

• 1 other identifier: IRC/2223/022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (2)

Drugs

ACTIVE COMPARATOR

oral combination of paracetamol (500mg) - ibuprofen (400mg) will be given to group A. they are provided in tablet and prescribed at 8 hourly for three days

Drug: Oral tablet and transdermal patch

Drug

ACTIVE COMPARATOR

Transdermal diclofenac patch - 200mg for group B. Patch is applied on right hand in deltoid region , and ask the patient to change patch every 24 hourly.

Drug: Oral tablet and transdermal patch

Interventions

Oral tablet and transdermal patch DRUG

oral combination of paracetamol -500mg and ibuprofen - 400mg will be given to group A and transdermal diclofenac patch - 200 mg will be given to group B.

Drug; Drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient indicated for surgical extraction of mandibular third molar -

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Niroj khanal

Dharān, Koshi, 56700, Nepal

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tablets; Transdermal Patch

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIROJ KHANAL

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 24, 2023
• Study Start: August 10, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

NE (1)