Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.
详细描述
Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.
Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.
Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.
To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages > 3 years and < 21 years
- •American Society of Anesthesiologists (ASA) class I or II
- •Fracture or dislocation requiring reduction under procedural sedation with ketamine as deemed by the attending emergency medicine physician
- •Parent/Legal Guardian or Patient (if 18 years of age or older) has already given verbal consent for procedural sedation as part of standard care for their condition
排除标准
- •Hypertension (Blood Pressure > 95th percentile for age)
- •Glaucoma or acute globe injury
- •Increased intracranial pressure or central nervous system mass lesion
- •Porphyria
- •Previous allergic reaction to ketamine
- •Previous allergic reaction to Propofol or its components including soybean oil, glycerol, egg lecithin, and disodium edentate
- •Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic hyperlipemia, or pancreatitis
- •Mitochondrial myopathies or disorders of electron transport
- •Pregnancy
- •Parent, guardian or patient unwilling/unable to provide informed consent/assent
研究组 & 干预措施
Ketamine Alone
1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
干预措施: Ketamine (Drug)
Ketamine Co-Administered with Propofol
0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
干预措施: Ketamine Co-administered with Propofol (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: From enrollment through completion of follow-up, up to 7 days
We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
次要结局
- Recovery Time(Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour)
- Parent Satisfaction(After procedure is completed, on average less than 1 hour)
- Physician Performing Procedure Satisfaction(After procedure is completed, on average less than 1 hour)
- Nurse Satisfaction(After procedure is completed, on average less than 1 hour)
- Efficacy of Sedation(After procedure is completed, on average less than 1 hour)