Procedural Sedation for Minor Procedures Using Jet-Injected Subcutaneous Ketamine
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of procedural success
研究概览
简要总结
The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods.
Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.
详细描述
This study will evaluate whether jet-injected ketamine can provide adequate sedation to perform minimally invasive procedures in children with heightened procedural sensitivity in a pediatric sedation clinic environment. Minimally invasive procedures include, but are not limited to, blood draws, IV placement, and immunizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to UW Health American Family Children's Hospital Pediatric Sedation Clinic for minimally invasive procedures such as blood draw, IV placement, or immunization
- •Age 2-15 years
- •Weight <40kg
排除标准
- •Participants with elevated intracranial pressure
- •Participants with uncontrolled hypertension
- •Participants who are pregnant or possibly pregnant (i.e., people of child bearing potential unable to provide a negative pregnancy test)
- •Participants who received a dose of medication within 2 hours of their appointment with the intention of sedation (i.e., benzodiazepines, opioids, alpha-2 agonists, 1st generation antihistamines)
- •Participants who are receiving medications which might enhance the sympathomimetic effect of ketamine (i.e., theophylline, aminophylline, amphetamine, or pseudoephedrine)
- •Participants who are receiving medications that might interfere with the expected pharmacokinetics of ketamine (i.e., ketoconazole, clarithromycin, rifampin, or carbamazepine)
- •Participant's parent/legal guardian requires a translator for communication about the patient's medical care
研究组 & 干预措施
J-tip jet injection
Participants will be given ketamine via J-tip jet injection
干预措施: Ketamine (Drug)
结局指标
主要结局
Feasibility of procedural success
时间窗: Up to 3 hours
Feasibility is measured by completion of the procedure using only the study drug. It is indicated by "yes" or "no".
次要结局
- Rate of procedural success(Up to 3 hours)
- Time it takes to achieve target PSSS score(Up to 20 minutes)
- Rate of adverse events(Up to 3 hours)