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Trial record 3 of 454 for:    DICLOFENAC

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

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ClinicalTrials.gov Identifier: NCT02547896
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Paulo Zupelari Goncalves, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: Codeine + Diclofenac Drug: Diclofenac Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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:
  • Lower third molar surgery
  • Pain control
  • NSAID




Primary Outcome Measures :
  1. Higher pain control after lower third molar surgeries with codeine + diclofenac [ Time Frame: Seven days after surgery ]
    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 :
  1. Adverse effects [ Time Frame: Seven days after surgery ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547896


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

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Responsible Party: Paulo Zupelari Goncalves, DDS., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02547896     History of Changes
Other Study ID Numbers: 30880914.1.0000.5417
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by Paulo Zupelari Goncalves, University of Sao Paulo:
codeine
diclofenac
impacted third molar tooth
Additional relevant MeSH terms:
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Diclofenac
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents