Impacted Third Molar Tooth, PAIN
Conditions
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.
Interventions
DRUGdiclofenac / acetaminophen /codeine
routine pain medication used post extraction of third molars
DRUGibuprofen/acetaminophen/codeine
routine pain medication used post extraction of third molars
Sponsors
UZ-CHS-PERFECT
University of Zimbabwe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| cheek swelling | with in 7 days post extraction | amount of cheek swelling post extraction |
| Time rescue medication is used | within 7 days post extraction | rescue medication |
Countries
Zimbabwe
Outcome results
None listed