Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of Sedation
研究概览
简要总结
Sedation and pain medication is required when bone fractures need to be fixed in the emergency department (ED). Many drugs have been used safely as single agents or in combination for the sedation of children. These drugs include Propofol, Ketamine and Fentanyl. However each of these medications has side effects and drawbacks. The combination of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study is to determine which combination works better. The primary outcome of this study is to determine which drug combination has a shorter time from onset of sedation to full recovery. The investigators hypothesize that Fentofol will have shorter sedation to recovery times.
详细描述
Purpose: The purpose of this study is to compare the duration of procedural sedation and analgesia (PSA) from time of medication delivery to recovery for children in the ED provided by Fentofol and Ketofol.
Hypothesis
The hypothesis is that Fentofol will have a shorter duration of sedation time as compared to Ketofol.
Justification: PSA for children is a common occurrence in the ED and has been performed using Ketamine or Propofol. Propofol offers several advantages over Ketamine, including shorter recovery times, and low rates of nausea and vomiting. Propofol is a potent sedative-hypnotic that does not provide analgesia, hence another agent is commonly used in combination for painful procedures. Propofol has been used in combination with Ketamine (Ketofol) and with Fentanyl (Fentofol) to improve the quality of sedation for painful procedures such as fracture reduction. Ketofol has been shown in a double blind randomized controlled trial to be at least equivalent, or even superior to Ketamine in children who are undergoing PSA, with shorter duration of sedation, increased provider and patient satisfaction, and reduced frequency of nausea/vomiting events. A combination of 1 to 2 microgram/kg Fentanyl and 1 mg/kg Propofol has been shown to substantially reduce recovery time as compared to 0.05 mg/kg Midazolam and 1 to 2 mg/kg Ketamine, and provided adequate levels of analgesia during PSA. As a result, both Ketofol and Fentofol are considered standard treatments for PSA in the ED. However, there is currently no pediatric literature available comparing Ketofol and Fentofol for PSA in the ED setting and the results of this study will potentially identify which of the two sedation agents is superior.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3-17 years of age
- •Presenting to the ED for assessment of a long bone fracture
- •Require PSA for closed reduction of the fracture
- •American Society of Anesthesia Grade I or II
排除标准
- •Families not providing informed consent (or assent where appropriate)
- •Families unable to communicate in English
- •Children sustained life- or limb-threatening injuries
- •Children involved in a multi-system trauma
- •Children with a pathological fractures
- •Children with a contraindication to using Propofol, Ketamine or Fentanyl:
- •Allergy or previous adverse reaction to study drugs Psychosis/schizophrenia Active upper respiratory tract infection or asthma, or chronic respiratory illnesses Coronary artery disease, congestive heart failure, hypertension, or chronic cardiac disease Chronic renal disease Increased intracranial pressure Porphyria or thyroid disorder
- •Severe developmental delay or autism
研究组 & 干预措施
Ketofol
Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol.
干预措施: Ketofol (Drug)
Fentofol
Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol.
干预措施: Fentofol (Drug)
结局指标
主要结局
Duration of Sedation
时间窗: Less than 30 minutes
Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.
次要结局
- Additional analgesia or sedation medications(Less than 30 minutes)
- Efficacy of sedation for completion of procedure(Less than 30 minutes)
- Recovery Time(Less than 30 minutes)
- Incidence of adverse events(From initiation of PSA until 48 to 72 hours post-ED discharge)
- Satisfaction with sedation(Less than 60 minutes)
研究者
Vikram Sabhaney
Principle Investigator
University of British Columbia