NCT01170247终止不适用
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Onset of Sedation
研究概览
简要总结
The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients age 2 to 17 years old
- •have a laceration of 4 cm on the face or 7 cm on the remainder of the body
- •Require procedural sedation to repair the laceration
排除标准
- •Patients with abnormal nasal physiology which would not allow for adequate medication delivery
- •Unable to have a guardian present to consent on their behalf
- •Allergy to ketamine
- •Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
- •Presenting with a head injury associated with possible intracranial hypertension
- •Pregnancy
- •Lacerations that require repair from a consult service
研究组 & 干预措施
Intranasal Ketamine
Experimental
干预措施: Ketamine (Drug)
Intramuscular Ketamine
Active Comparator
干预措施: Ketamine (Drug)
结局指标
主要结局
Onset of Sedation
时间窗: Every 60 seconds through study completion
Minutes it takes until the patient is cooperative enough for the procedure
次要结局
未报告次要终点
研究者
Brett A Faine
Clinical Pharmacy Specialist
University of Iowa
研究点 (1)
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