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

University of Zimbabwe78 enrolled

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 .

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Impacted Third Molar Tooth PAIN

Interventions

diclofenac / acetaminophen /codeineDRUG

routine pain medication used post extraction of third molars

ibuprofen/acetaminophen/codeineDRUG

routine pain medication used post extraction of third molars

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr Silas bere

Harare, Zimbabwe

Outcomes

Primary Outcomes

post operative pain

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.

Time frame: within 7 days post extraction

Secondary Outcomes

Time rescue medication is used

rescue medication

Time frame: within 7 days post extraction

cheek swelling

amount of cheek swelling post extraction

Time frame: with in 7 days post extraction

Data from ClinicalTrials.gov

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