Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
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.
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2014
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedSeptember 11, 2015
September 1, 2015
9 months
September 10, 2015
September 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Adverse effects
Seven days after surgery
Study Arms (2)
Pain control using codeine + diclofenac
EXPERIMENTALFifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of codeine + 50mg of diclofenac
Pain control using diclofenac
EXPERIMENTALFifty healthy volunteers underwent removal of symmetrically positioned lower third molars, receiving for pain relief after the procedure 50mg of diclofenac
Interventions
The patients will receive codeine and diclofenac as pain relief medicine after the surgery
The patients will receive only diclofenac
Eligibility Criteria
You may qualify if:
- Impacted lower third molar
- not in use of NSAID or opioids in the last one month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paulo Z Goncalves, DDS
Bauru School of Dentistry - University of Sao Paulo - USP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS.
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
September 11, 2015
Record last verified: 2015-09