Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Post operatory pain
研究概览
简要总结
Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.
The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock
详细描述
A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral impacted lower third molar
排除标准
- •NSAID allergic
- •Contraindication of surgery
研究组 & 干预措施
Morning dosage
Dexketoprofen pill at morning; Placebo at night
干预措施: Dexketoprofen 25 MG (Drug)
Night dosage
Placebo pill at morning; Dexketoprofen at night
干预措施: Dexketoprofen 25 MG (Drug)
结局指标
主要结局
Post operatory pain
时间窗: From the day of the surgical procedure to the seventh-day
Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))
次要结局
- Swelling(Baseline and post operatory (day 1, day 3, day 7))
研究者
Jesús Torres García Denche
Associate professor
Universidad Complutense de Madrid