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

A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery

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 .

Study Overview

• Status: Suspended
• Conditions: Impacted Third Molar Tooth; PAIN
• Intervention / Treatment: Drug: diclofenac / acetaminophen /codeine; Drug: ibuprofen/acetaminophen/codeine

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zimbabwe
  • Harare, Zimbabwe, 00263
    • Dr Silas bere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 7 days post extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time rescue medication is used	rescue medication	within 7 days post extraction
cheek swelling	amount of cheek swelling post extraction	with in 7 days post extraction

Collaborators and Investigators

• Sponsor: University of Zimbabwe
• Collaborators: UZ-CHS-PERFECT

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Diclofenac; Ibuprofen; Codeine
• Other Study ID Numbers: UZCHS PERFECT THIRD MOLAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No