Overview

Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universita di Verona
Treatments:
Analgesics
Etoricoxib
Ibuprofen
Criteria
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