Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 主要终点
- analgesic efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Etoricoxib
Etoricoxib 120 mg/day x 3 days
干预措施: etoricoxib (Drug)
Ibuprofen
Ibuprofen 1800 mg/day x 3 days
干预措施: ibuprofen (Drug)
结局指标
主要结局
analgesic efficacy
时间窗: 3 days
次要结局
- side effects(3 days)
