The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in pain
研究概览
简要总结
The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.
详细描述
The surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. Pain following these operations is one of the most important factors affecting patient satisfaction. Several pain-management strategies are available. An alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally.
Tramadol is a centrally acting opioid that provides good analgesia. It reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies.
The aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.
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 (Care Provider, Investigator)
盲法说明
The solutions were prepared prior to the procedure by an anesthetic nurse who was not involved in the study. Investigator was blind to the groups.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score of ASA I-II (American Society of Anesthesiologists Physical Status I or II)
- •Patient weights were less than 60 kg
排除标准
- •Subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h,
- •Sensitive to tramadol,
- •Patients who needed an extra dose of anesthetic solution during the surgery
研究组 & 干预措施
Only local anesthetic group
干预措施: Only local anesthetic (Drug)
Tramadol group
干预措施: Local anesthetic + tramadol hydrochloride (Drug)
结局指标
主要结局
Change in pain
时间窗: 48 hours
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. VAS values were taken from the patient during; post-op 10 minutes, hour 1, hour 2, hour 4, hour 6, hour 12, hour 24, hour 48.
次要结局
- Change in heart rate(60 minutes)
- Change in mean blood pressure(60 minutes)