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

NCT ID: NCT02547896

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain control using 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

Group Type: EXPERIMENTAL

Codeine + Diclofenac

Intervention Type: DRUG

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

Pain control using diclofenac

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

Group Type: EXPERIMENTAL

Diclofenac

Intervention Type: DRUG

The patients will receive only diclofenac

Interventions

Codeine + Diclofenac

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

Intervention Type: DRUG

Diclofenac

The patients will receive only diclofenac

Intervention Type: DRUG

Other Intervention Names

Lower third molar surgery; Pain control; NSAID associated with Opioids; Lower third molar surgery; Pain control; NSAID

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Paulo Zupelari Goncalves

DDS.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Z Goncalves, DDS

Role: STUDY_CHAIR

Bauru School of Dentistry - University of Sao Paulo - USP

Other Identifiers

30880914.1.0000.5417

Identifier Type: -

Identifier Source: org_study_id