Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Phase 4

• Conditions: Dental Extraction
• Interventions: Drug: etoricoxib; Drug: ibuprofen

• Registration Number: NCT00855777
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-03
• Last Update Submitted: 2009-03-03
• Study First Posted: 2009-03-04
• Last Update Posted: 2009-03-04
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etoricoxib	etoricoxib	Etoricoxib 120 mg/day x 3 days
Ibuprofen	ibuprofen	Ibuprofen 1800 mg/day x 3 days

Primary Outcome Measures

Name	Time	Method
analgesic efficacy	3 days

Secondary Outcome Measures

Name	Time	Method
side effects	3 days