Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Post-surgical swelling of third molar extraction determined using linear measures in the face
研究概览
简要总结
The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.
详细描述
The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication of asymptomatic bilateral extractions of lower third molars;
- •Aged 18 years or older;
- •Have a good health and no disease;
排除标准
- •Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.
研究组 & 干预措施
Dexamethasone
Dexamethasone 8 mg, one capsule single preoperative dose.
干预措施: Dexamethasone (Drug)
Diclofenac Sodium associated with Codeine
Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.
干预措施: Diclofenac Sodium associated with Codeine (Drug)
结局指标
主要结局
Post-surgical swelling of third molar extraction determined using linear measures in the face
时间窗: Up to seven days post-surgical
During the post-surgical intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face.
Post-surgical trismus of third molar extraction determined by maximum mouth opening
时间窗: Up to seven days post-surgical
During the post-surgical intervals of 24, 48 and 72 hours and seven days, the trismus was determined by maximum mouth opening.
Post-surgical pain of third molar extraction using visual analogic scale
时间窗: Up to seven days post-surgical
The post-surgical pain was self-recorded by the patient using visual analogic scale in intervals of 24, 48 and 72 hours and seven days.
次要结局
- Analgesic consumption(Up to seven days post-surgical)
- Duration of surgery(Up to seven days post-surgical)