Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Sum pain NRS
研究概览
简要总结
The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars
详细描述
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for removal of third molar
- •Between 20 and 30 years of age
- •ASA Class 1
排除标准
- •Psychiatric family (father/mother) or own anamnestic history
- •Hypersensitivity towards NSAIDS or other rescue analgesics
- •Verified or suspected pregnancy
- •Lactating females
- •Surgery lasting over 60 min
研究组 & 干预措施
Placebo males
Saline physiological placebo males
干预措施: Placebo males (Drug)
Ketamine 0,1 mg/kg males
0,1 mg/kg ketamine males
干预措施: Ketamine 0,1 mg/kg males (Drug)
Ketamine 0,3 mg/kg males
0,3 mg/kg ketamine males
干预措施: Ketamine 0,3 mg/kg males (Drug)
Ketamine 0,5 mg/kg males
0,5 mg/kg ketamine males
干预措施: Ketamine 0,5 mg/kg males (Drug)
Placebo females
Saline physiological as placebo females
干预措施: Placebo females (Drug)
Ketamine 0.1 mg/kg females
0,1 mg/kg ketamine females
干预措施: Ketamine 0,1 mg/kg females (Drug)
Ketamine 0,3 mg/kg females
0,3 mg/kg ketamine females
干预措施: Ketamine 0,3 mg/kg females (Drug)
Ketamine 0,5 mg/kg females
0,5 mg/kg ketamine females
干预措施: Ketamine 0,5 mg/kg females (Drug)
结局指标
主要结局
Sum pain NRS
时间窗: 60 min
次要结局
- Several subjective variables assessing psychotomimetic effects(0, 15, 60)