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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Impacted Third Molar Tooth

Treatments: Drug: Diclofenac; Drug: Codeine + Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT02547896

30880914.1.0000.5417

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Pain control using codeine + diclofenac

Experimental group

Description:

Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of codeine + 50mg of diclofenac

Treatment:

Drug: Codeine + Diclofenac

Pain control using diclofenac

Experimental group

Description:

Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of diclofenac

Treatment:

Drug: Diclofenac