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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Codeine + Diclofenac
Diclofenac
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring codeine, diclofenac, impacted third molar tooth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Pain control using codeine + diclofenac

    Pain control using diclofenac

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 10, 2015
    Last Updated
    September 10, 2015
    Sponsor
    University of Sao Paulo
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02547896
    Brief Title
    Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth
    Keywords
    codeine, diclofenac, impacted third molar tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pain control using codeine + diclofenac
    Arm Type
    Experimental
    Arm Description
    Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of codeine + 50mg of diclofenac
    Arm Title
    Pain control using diclofenac
    Arm Type
    Experimental
    Arm Description
    Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of diclofenac
    Intervention Type
    Drug
    Intervention Name(s)
    Codeine + Diclofenac
    Other Intervention Name(s)
    Lower third molar surgery, Pain control, NSAID associated with Opioids
    Intervention Description
    The patients will receive codeine and diclofenac as pain relief medicine after the surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac
    Other Intervention Name(s)
    Lower third molar surgery, Pain control, NSAID
    Intervention Description
    The patients will receive only diclofenac
    Primary Outcome Measure Information:
    Title
    Higher pain control after lower third molar surgeries with codeine + diclofenac
    Description
    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.
    Time Frame
    Seven days after surgery
    Secondary Outcome Measure Information:
    Title
    Adverse effects
    Description
    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.
    Time Frame
    Seven days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paulo Z Goncalves, DDS
    Organizational Affiliation
    Bauru School of Dentistry - University of Sao Paulo - USP
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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