Perioperative Administration of Pregabalin for Pain After Septoplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
研究概览
简要总结
Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Persons who scheduled for elective septoplasty under general anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours postoperatively.
详细描述
Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Patients will be randomly assigned to one of two groups to receive either pregabalin (Lyrica®, Pfizer, Inc.) or placebo (vitamin complex). According to their assigned study group, patients received either pregabalin (75 mg) or placebo twice, one hour before surgery and 12 hours after the initial dose. The assessment of pain and side effects, such as nausea and vomiting, headache, dizziness, sedation, and blurred vision, were made at one, six, 12, and 24 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 ≥ and ≤ 65 years
- •Patients with nasal packing after septoplasty
排除标准
- •previous septal surgery history
- •postoperative complications including septal hematoma, bleeding ets.
- •Current therapy with pregabalin, gabapentin, or any opioid
- •Renal insufficiency
- •History of seizure disorder
研究组 & 干预措施
Pregabalin
Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later
干预措施: Pregabalin (Lyrica) (Drug)
Placebo
Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later
干预措施: Vitamin complex (placebo) (Drug)
结局指标
主要结局
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
时间窗: postoperative 24 hrs
次要结局
- The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness(postoperative 1, 6, 12, 24 hours)
- The number of patients who required additional analgesics during admission(postoperative 1,6,12,24 hour)
- Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)(postoperative 1, 6, 12 hours)