An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

Overview

Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .

Full Title of Study: “A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Detailed Description

Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.

Interventions

  • Drug: diclofenac / acetaminophen /codeine
    • routine pain medication used post extraction of third molars
  • Drug: ibuprofen/acetaminophen/codeine
    • routine pain medication used post extraction of third molars

Arms, Groups and Cohorts

  • Active Comparator: Diclofenac /Acetaminophen/Codeine
    • routine pain medication used in post extraction pain management
  • Active Comparator: Ibuprofen/Acetaminophen/codeine
    • routine pain medication used in post extraction pain management

Clinical Trial Outcome Measures

Primary Measures

  • post operative pain
    • Time Frame: within 7 days post extraction
    • record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.

Secondary Measures

  • Time rescue medication is used
    • Time Frame: within 7 days post extraction
    • rescue medication
  • cheek swelling
    • Time Frame: with in 7 days post extraction
    • amount of cheek swelling post extraction

Participating in This Clinical Trial

Inclusion Criteria

  • patients older than 18 years of age – patients undergoing third molar extractions – patients with or willing to get orthopantomogram for assessment of impacted third molars Exclusion Criteria:

  • patients younger than 18 years – patients not willing to consent to the study – patients with associated co-morbidities – patients not willing to undergo radiological evaluation – patients allergic to medications used in the study – pregnant patients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zimbabwe
  • Collaborator
    • UZ-CHS-PERFECT
  • Provider of Information About this Clinical Study
    • Principal Investigator: Silas Bere, Lecturer – University of Zimbabwe

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