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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02547896
Other study ID # 30880914.1.0000.5417
Secondary ID
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


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
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