Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

Conditions
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Dental Extraction

Intervention / Treatment
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* Drug: etoricoxib
* Drug: ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib<br>Etoricoxib 120 mg/day x 3 days | Drug: etoricoxib<br>* etoricoxib 120 mg/day for 3 days<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 1800 mg/day x 3 days | Drug: ibuprofen<br>* ibuprofen 1,800 mg/day for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic efficacy |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third molar extraction, etoricoxib, ibuprofen, analgesic efficacy, pain