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

University of Zimbabwe (Other)
Overall Status
Suspended ID

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Actual Enrollment :
78 participants
Intervention Model:
Parallel Assignment
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diclofenac /Acetaminophen/Codeine

routine pain medication used in post extraction pain management

Drug: diclofenac / acetaminophen /codeine
routine pain medication used post extraction of third molars
Other Names:
  • diclofenac/paracetamol/codeine phosphate
  • Active Comparator: Ibuprofen/Acetaminophen/codeine

    routine pain medication used in post extraction pain management

    Drug: ibuprofen/acetaminophen/codeine
    routine pain medication used post extraction of third molars
    Other Names:
  • ibuprofen/paracetamol/codeine phosphate
  • Outcome Measures

    Primary Outcome Measures

    1. post operative pain [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 Outcome Measures

    1. Time rescue medication is used [within 7 days post extraction]

      rescue medication

    2. cheek swelling [with in 7 days post extraction]

      amount of cheek swelling post extraction

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Dr Silas bere Harare Zimbabwe 00263

    Sponsors and Collaborators

    • University of Zimbabwe


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Silas Bere, Lecturer, University of Zimbabwe Identifier:
    Other Study ID Numbers:
    First Posted:
    May 6, 2021
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2021