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

Not Applicable

Suspended

• Conditions: Impacted Third Molar Tooth; PAIN
• Interventions: Drug: ibuprofen/acetaminophen/codeine; Drug: diclofenac / acetaminophen /codeine

• Registration Number: NCT04874675
• Lead Sponsor: University of Zimbabwe

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 .

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 Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05
• Study Start: 2023-03
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen/Acetaminophen/codeine	ibuprofen/acetaminophen/codeine	routine pain medication used in post extraction pain management
Diclofenac /Acetaminophen/Codeine	diclofenac / acetaminophen /codeine	routine pain medication used in post extraction pain management

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time rescue medication is used	within 7 days post extraction	rescue medication
cheek swelling	with in 7 days post extraction	amount of cheek swelling post extraction

Trial Locations

Locations (1)

Dr Silas bere; 🇿🇼 Harare, Zimbabwe