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Completed

NCT Number: NCT02547896

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

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.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Codeine + Diclofenac

Drug

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

Diclofenac

Drug

The patients will receive only diclofenac

Other names: Lower third molar surgery, Pain control, NSAID

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2015
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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