Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Successful procedural sedation
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
- •Body weight of 20kg or less (actual, estimated, or measured)
- •NPO for four hours or more
- •Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.
排除标准
- •Discretion of parents
- •Discretion of provider
- •Body weight greater than 20kg (actual, estimated, or measured)
- •Starting Aldrete score <9/10
- •Known or suspected psychosis
- •Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
- •Significant elevation in blood pressure
- •Known hypersensitivity to ketamine
- •Non-English or Spanish speaking
研究组 & 干预措施
Intranasal ketamine arm
10mg/kg intranasal ketamine administered one time
干预措施: Ketamine Hcl 100Mg/Ml Inj (Drug)
结局指标
主要结局
Successful procedural sedation
时间窗: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).
Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
次要结局
未报告次要终点
研究者
Vivienne Ng
Physician
University of Arizona