Effect of Nicotine on Pain After Third Molar Extraction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Reported by Patient
研究概览
简要总结
Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.
详细描述
This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 molars to be removed
排除标准
- •lactating
- •chronic pain
- •narcotic use
- •ex-smokers
研究组 & 干预措施
Nicotine nasal spray
In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.
干预措施: Nicotine (Drug)
Placebo spray
In one sitting the subject will receive a placebo nasal spray (0 mg), one application.
干预措施: Placebo (Other)
结局指标
主要结局
Pain Reported by Patient
时间窗: Up to 1 day
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
次要结局
- Heart Rate(5 days)
- Systolic Blood Pressure(5 days)
- Diastolic Blood Pressure(5 days)
- Difference in Amount of Nausea Reported(5 days)
- Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery(5 days)