Dental Extraction Clinical Trial
Official title:
Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a
well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar
extraction pain. At this time, there are no data about the efficacy of etoricoxib for
reducing pain following dental extraction.
This will be a single center, randomized, double-blind study, in which patients with
moderate to severe pain following third molar extraction will be randomized to receive
etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen
(1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue
medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no
pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will
be enrolled 15 days before the dental extraction. During enrollment visit a complete
clinical evaluation with particular attention for potential exclusion criteria (e.g.
hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A
follow-up visit will be performed 15 days after the dental extraction. Tolerability will be
assessed through recording of adverse events.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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