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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-04-30

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Impacted Third Molar Tooth PAIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac /Acetaminophen/Codeine

routine pain medication used in post extraction pain management

Group Type ACTIVE_COMPARATOR

diclofenac / acetaminophen /codeine

Intervention Type DRUG

routine pain medication used post extraction of third molars

Ibuprofen/Acetaminophen/codeine

routine pain medication used in post extraction pain management

Group Type ACTIVE_COMPARATOR

ibuprofen/acetaminophen/codeine

Intervention Type DRUG

routine pain medication used post extraction of third molars

Interventions

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diclofenac / acetaminophen /codeine

routine pain medication used post extraction of third molars

Intervention Type DRUG

ibuprofen/acetaminophen/codeine

routine pain medication used post extraction of third molars

Intervention Type DRUG

Other Intervention Names

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diclofenac/paracetamol/codeine phosphate ibuprofen/paracetamol/codeine phosphate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes