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

Impacted Third Molar Tooth Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547896
• Other study ID #: 30880914.1.0000.5417
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2015
• Last updated: September 10, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Drug:
• Codeine + Diclofenac
The patients will receive codeine and diclofenac as pain relief medicine after the surgery
• Diclofenac
The patients will receive only diclofenac

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes