NCT02696369已完成4 期
A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Pain visual analogue scale (VAS)
研究概览
简要总结
This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19
- •Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
- •Mesioangular or horizontal angulation categorized by winter classification
排除标准
- •Allergy or hypersensitivity about the investigated products
- •Any infection or edema during the extraction
- •The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
- •Pregnancy or breast-feeding
- •Any conditions that the investigator considers not to appropriate for this study
结局指标
主要结局
Pain visual analogue scale (VAS)
时间窗: Immediately after the extraction
To acess the pain immediately after the surgical extraction of impacted lower third molars
次要结局
- Pain VAS(2, 4, 6 hours after administration of the investigational product (IP))
- Bleeding after extraction measured by the operator(Immediately after extraction)
- Local anesthetic duration(Immediately after onset of anesthesia)
- Questionnaire of satisfaction level of the operator(Immediately after extraction)
- Questionnaire of satisfaction level of the subjects(Immediately after extraction)
- Dosage of administrated IP(immediately after injection)
- Onset time of anesthesia(Immediately after administration of IP)
- Onset time of pain after administration of IP(Immediately after injection)
研究者
研究点 (2)
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