Assessing the Frequency of Lidocaine Ineffectiveness in the General Population vs. Males With ADHD, and Females With ADHD, With or Without PMS
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of Subjects With Lidocaine Ineffectiveness
研究概览
简要总结
This work will assess the prevalence in the general population of the ineffectiveness of the anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.
详细描述
Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population. We will use an identical protocol at two sites: Jacobi hospital and Boston Clinical Trials.
The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 100 teens and adults, half with a history of ADHD, and for females, we will compare the sub-groups with and without premenstrual syndrome (PMS).
This study will also be compared with a similar assessment among a specialized ADHD population (NCT03563573), that does not respond to existing medication..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will not be shared with the testing site until all testing is complete.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria for both arms:
- •(1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.
排除标准
- 未提供
研究组 & 干预措施
All subjects
All subjects get the lidocaine taste test
干预措施: Lidocaine gel (Drug)
结局指标
主要结局
Number of Subjects With Lidocaine Ineffectiveness
时间窗: 30 minute visit, added on to a regular clinic visit
Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective.
次要结局
未报告次要终点