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

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.

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.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Codeine + Diclofenac; Drug: Diclofenac

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Codeine + Diclofenac; The patients will receive codeine and diclofenac as pain relief medicine after the surgery; Other Names: Lower third molar surgery; Pain control; NSAID associated with Opioids
Experimental: 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	Drug: Diclofenac; The patients will receive only diclofenac; Other Names: NSAID; Lower third molar surgery; Pain control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Study Chair: Paulo Z Goncalves, DDS, Bauru School of Dentistry - University of Sao Paulo - USP

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: diclofenac; codeine; impacted third molar tooth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Codeine
• Other Study ID Numbers: 30880914.1.0000.5417