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

PAIN Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04874675
• Other study ID #: UZCHS PERFECT THIRD MOLAR
• Status: Suspended
• Phase: N/A
• Start date: March 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2023
• Source: University of Zimbabwe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 78
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• PAIN
• Tooth, Impacted

Intervention

Drug:
• diclofenac / acetaminophen /codeine
routine pain medication used post extraction of third molars
• ibuprofen/acetaminophen/codeine
routine pain medication used post extraction of third molars

Locations

Country	Name	City	State
Zimbabwe	Dr Silas bere	Harare

Sponsors (2)

Lead Sponsor	Collaborator
University of Zimbabwe	UZ-CHS-PERFECT

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time rescue medication is used	rescue medication	within 7 days post extraction
Secondary	cheek swelling	amount of cheek swelling post extraction	with in 7 days post extraction