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

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: Codeine + Diclofenac; Drug: Diclofenac

• Registration Number: NCT02547896
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Last Update Submitted: 2015-09-10
• Study First Posted: 2015-09-11
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pain control using codeine + diclofenac	Codeine + Diclofenac	Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of codeine + 50mg of diclofenac
Pain control using diclofenac	Diclofenac	Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of diclofenac

Primary Outcome Measures

Name	Time	Method
Higher pain control after lower third molar surgeries with codeine + diclofenac	Seven days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	Seven days after surgery	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.