This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
Individual drug
Individual drug
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, Brazil
Superiority of the Fixed Dose Combination versus Isolated active substances
The Primary outcome will be accessed by the individual response rate in relation to the pain intensity calculated by the Visual Analogic Scale (VAS) scale performed after 4 hours of administration of the first dose of medicines
Time frame: 4 hours
Individual response rate
Individual response rate in relation to the evaluation of pain intensity calculated through the Visual Analogic Scale (VAS) measure in times 6h, 12h, 24h, 48h and 72h
Time frame: 6h, 12h, 24h, 48h and 72h
Edema
Absence of edema after 4 hours of drug administration and at the end of treatment
Time frame: 4 hours
Mandibula constriction
Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
Time frame: 4 hours
Use of rescue medication
Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group
Time frame: 3 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.