Dental Extraction
Conditions
Keywords
third molar extraction, etoricoxib, ibuprofen, analgesic efficacy, pain
Brief summary
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.
Interventions
DRUGetoricoxib
etoricoxib 120 mg/day for 3 days
DRUGibuprofen
ibuprofen 1,800 mg/day for 3 days
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects with age \> 18 years * in good health status (assessed in occasion of enrollment visit) without any major systemic illness * candidate to third molar extraction and presenting local pain within 2 hours after dental extraction
Exclusion criteria
* patients with any major systemic illness * patients with a clinical history of drug abuse * patients with hypertension and/or a condition of increased cardiovascular risk * pregnant or lactating women * patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs * patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval) * patients with either a history of peptic ulcer or of haemorrhagic diathesis * patients who can not ensure an adequate compliance for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| analgesic efficacy | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| side effects | 3 days |
Contacts
Primary ContactRoberto Corrocher, MD
Outcome results
None listed