Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.

Study Overview
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Brief Summary
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It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of two third molars. After assessing the research parameters, a comparative data analysis, along with the proper application of statistical tests, will provide the basis for an evaluation of both efficiency medications used.

Detailed Description
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This research will evaluate the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients aged less than 18 and requiring extraction of two third molars (with very similar positions, whose degree of difficulty is high). It will be assessed the following parameters: 1) onset and duration of surgery after administration of local anesthetic, 2) open mouth prior to surgery, on the 2nd day after the operation and on the 7th day after surgery (removal points), 3) subjective assessment of pain using a visual analog scale, 4) measurement of facial edema in the second day after the operation and on the 7th day after surgery (as compared with the measurements obtained before surgery) and 5) the incidence, type and severity of adverse reactions. The analysis comparative data, along with the proper application of statistical tests, provide the basis for an evaluation of both efficiency medications used.

Official Title
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Effectiveness of Non-steroidal Anti-inflammatory Diclofenac and Its Association to the Opioid Codeine for Pain, Swelling and Trismus in the Bilateral Mandibular Third Molar Extraction With a High Degree of Difficulty Model.

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: Codeine + Diclofenac
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Impacted lower third molar not in use of NSAID or opioids in the last one month Exclusion Criteria: Local anesthetics allergy, History of gastrointestinal bleeding or ulcers, Kidney disease, Asthma, Allergy or sensitivity to aspirin or any other NSAID or opioids, Pregnant or nursing woman, Patients using antidepressant, diuretic or aspirin, Patients under treatment to quit drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain control using codeine + diclofenac<br>Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of codeine + 50mg of diclofenac | Drug: Codeine + Diclofenac<br>* The patients will receive codeine and diclofenac as pain relief medicine after the surgery<br>* Other names: NSAID associated with Opioids;|
| Experimental: Pain control using diclofenac<br>Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of diclofenac | Drug: Diclofenac<br>* The patients will receive only diclofenac<br>* Other names: NSAID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher pain control after lower third molar surgeries with codeine + diclofenac | Reducing pain is measured by visual analogue scale. It is expected that the visual analogue scale (100 mm) presents lower values in patients that underwent surgeries and received the association of codeine + diclofenac compared to whose received only diclofenac. Evaluated periods were 0, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 and 96 hours. | Seven days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Increased reporting of adverse effects during the postoperative period in patients that received codeine + diclofenac assessed by the information contained in the medical records of the patient. | Seven days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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codeine, diclofenac, impacted third molar tooth