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

University of Sao Paulo50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impacted Third Molar Tooth

Interventions

Codeine + DiclofenacDRUG

The patients will receive codeine and diclofenac as pain relief medicine after the surgery

DiclofenacDRUG

The patients will receive only diclofenac

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Seven days after surgery

Secondary Outcomes

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.

Time frame: Seven days after surgery

Data from ClinicalTrials.gov

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