Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
研究概览
简要总结
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
详细描述
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1-18 years of age.
- •American Society of Anesthesiologists (ASA) I or II
- •Non-operative fracture requiring reduction
- •Body weight less than or equal to 25 kg as measured by standard weighing scale
排除标准
- •ASA classification III or above
- •Age less than 1 year
- •History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder
- •Prior allergy to ketamine
- •Unavailable parent or guardian to provide consent
- •Non-English speaking
研究组 & 干预措施
Intravenous ketamine
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
干预措施: Intravenous Ketamine (Drug)
Intranasal ketamine
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
干预措施: Intranasal Ketamine (Drug)
结局指标
主要结局
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
时间窗: From induction to discharge from sedation by emergency physician, up to 3 hours.
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.
Number of Participants Who Achieved Adequate Sedation.
时间窗: Induction up to 10 minutes
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
次要结局
- Percentage of Participants With Non-serious Adverse Events.(From induction to discharge from the emergency department.)
- Duration of Emergency Department Stay.(From arrival to emergency department to discharge order entered by emergency physician.)
- Duration of Sedation Using Modified Ramsay Sedation Scale.(From induction to discharge from sedation by the emergency physician.)
研究者
James Statler
Pediatric Emergency Medicine Fellow
University of Alabama at Birmingham