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
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
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
NCT ID
NCT02547896
First Posted
September 10, 2015
Last Updated
September 10, 2015
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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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