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

NCT04874675 | Suspended DMC

• 1 other identifier: UZCHS PERFECT THIRD MOLAR
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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 .

Conditions

Impacted Third Molar Tooth; PAIN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time rescue medication is used

  within 7 days post extraction

• cheek swelling

  with in 7 days post extraction

Study Arms (2)

Diclofenac /Acetaminophen/Codeine

ACTIVE COMPARATOR

routine pain medication used in post extraction pain management

Drug: diclofenac / acetaminophen /codeine

Ibuprofen/Acetaminophen/codeine

ACTIVE COMPARATOR

routine pain medication used in post extraction pain management

Drug: ibuprofen/acetaminophen/codeine

Interventions

diclofenac / acetaminophen /codeine DRUG

routine pain medication used post extraction of third molars

Also known as: diclofenac/paracetamol/codeine phosphate

Diclofenac /Acetaminophen/Codeine

ibuprofen/acetaminophen/codeine DRUG

routine pain medication used post extraction of third molars

Also known as: ibuprofen/paracetamol/codeine phosphate

Ibuprofen/Acetaminophen/codeine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zimbabwe: lead
• UZ-CHS-PERFECT: collaborator

Study Sites (1)

Dr Silas bere

Harare, 00263, Zimbabwe

Location

MeSH Terms

Conditions

Pain

Interventions

Diclofenac; Acetaminophen; Codeine; Ibuprofen; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 6, 2021
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

ZI (1)