Prevalence of Lidocaine Ineffectiveness in Those With Hard-to-treat ADHD
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
研究概览
简要总结
This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.
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.
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.
This is one of the last studies with an IRB for each arm and site. Hence it appears to be a single arm, but the other arms are separately registered with ClinicalTrials.gov
入排标准
- 年龄范围
- 7 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria for both arms:
- •known adverse reactions to lidocaine
- •epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism;
- •treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
- •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);
- •mouth sores;
- •Ehlers Danlos syndrome, and
排除标准
- 未提供
研究组 & 干预措施
Observational study of prevalence in hard-to-treat ADHD
Subjects will be tested with lidocaine gel.
干预措施: Lidocaine gel (Drug)
结局指标
主要结局
Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
时间窗: on day of testing, approximately 30 minutes for clinic visit
Subjects will be asked to identify each taste and its intensity.
次要结局
未报告次要终点