Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic
研究概览
简要总结
A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region
详细描述
A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed by applying a microneedle patch and as a negative control the an identical patch but without microneedles sticking out and after the topical anesthetic was applied for in one session 2 minutes and the other session 5 minutes and the investigators evaluated the pain of needle introduction and the injection of the anesthetic.
The application force of the microneedles was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), in these two different moments, introduction of the needle and injection of the anesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Every volunteers has received bilateral pre-treatment with microneedles or the negative control in the palatal mucosa, in both sessions, which each session was 2 minutes of topical anesthetic or 5 minutes.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
排除标准
- •Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.
研究组 & 干预措施
Microneedles
Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic
干预措施: Topical Anesthetic (Drug)
Microneedles
Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic
干预措施: Local anesthetic (Drug)
patch flat
The same device as the microneedles but without microneedles
干预措施: Topical Anesthetic (Drug)
patch flat
The same device as the microneedles but without microneedles
干预措施: Local anesthetic (Drug)
结局指标
主要结局
Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic
时间窗: 2 minutes or 5 minutes
Microneedles or the negative control were used to prepare the palatal mucosa to receive the topical anesthetic, followed by the insertion of the needle and injection of the local anesthetic, evaluating whether the microneedles improve the effectiveness of the topical agent with a Visual Analogic Scale. The blind investigator, evaluated the values with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a higher score means a worse outcome,
次要结局
未报告次要终点
研究者
Michelle Franz Montan Braga Leite, DDS, MSc, PhD
Principal Investigator
University of Campinas, Brazil