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

University of Zimbabwe

Status: Suspended

Conditions: PAIN; Impacted Third Molar Tooth

Treatments: Drug: diclofenac / acetaminophen /codeine; Drug: ibuprofen/acetaminophen/codeine

Study type: Interventional

Funder types: Other

Identifiers

NCT04874675

UZCHS PERFECT THIRD MOLAR

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

Diclofenac /Acetaminophen/Codeine

Active Comparator group

Description:

routine pain medication used in post extraction pain management

Treatment:

Drug: diclofenac / acetaminophen /codeine

Ibuprofen/Acetaminophen/codeine

Active Comparator group

Description:

routine pain medication used in post extraction pain management

Treatment:

Drug: ibuprofen/acetaminophen/codeine