NCT00846690Unknown4 期
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- visual analogue scale score
研究概览
简要总结
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).
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 (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers 18 years or older
- •Ability to consent to participate in the research
- •Ability to communicate a VAS score
- •Generally healthy, ASA I and ASA II
- •No known drug allergies
- •Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence
排除标准
- •Allergy or other contraindications to the topical anesthetics
- •Inability to consent to participation in the study
- •Use of analgesics prior to the procedure
- •Vulnerable populations
研究组 & 干预措施
Benzocaine
Active Comparator
serves as "active" control
干预措施: benzocaine (Drug)
TAC
Experimental
serves as comparator
干预措施: TAC alternate gel (Drug)
结局指标
主要结局
visual analogue scale score
时间窗: pre-op, insertion, every minute post-op for 10 minutes
次要结局
- blood pressure(three times pre-op, insertion, ten times post-op)
- oxygen saturation(three times pre-op, insertion, ten times post-op)
- heart rate(three times pre-op, insertion, ten times post-op)
研究者
研究点 (1)
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