Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Motor score scale from baseline
研究概览
简要总结
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. The investigators want to see if in pediatric patients, giving Zofran prior to propofol, reduces the pain that patients often experience when propofol is injected through an IV. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. The investigators hope to show a means of improving pain control in their patients undergoing anesthesia.
详细描述
Propofol is a drug commonly used at the beginning of anesthesia (induction). Patients often experience discomfort when propofol is injected through an IV. Ondansetron (Zofran) is a drug that is commonly used to treat nausea after anesthesia. In adult studies, it has been shown that there is significantly less pain when Zofran is given just before propofol is given. The investigators want to see if giving Zofran prior to propofol reduces the pain and discomfort experienced by pediatric patients.
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. During induction the treating anesthesiologist will be blinded to the study arm, however they will be unblinded at the end of induction. All subjects will receive Zofran at some point during the surgery - for patients not in the Zofran arm, they will receive it at the end of the case as usual. A blinded observer will score the subject's pain during propofol injection and vital signs will be recorded.
Subjects will be identified by the study team from the surgery schedule. Patients ages 2-17 undergoing surgery with peripheral vascular access (an IV) will be approached. Consent and assent (when appropriate) will be obtained. Subjects will not be compensated. Participation will consist only of the single duration of the surgery.
In this study the investigators hope to show a means of improving pain control in their patients undergoing anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 否
入选标准
- •Patients 2 years old through 17 years of age
- •Children undergoing surgery at Children's Healthcare of Atlanta Egleston location
- •Patient with existing peripheral vascular access in the arm below the antecubital fossa
- •Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3
- •Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
- •No known chronic pain syndrome
排除标准
- •Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
- •Known chronic pain syndrome
- •Patient diagnosed with long QT syndrome
- •Patient weighing >40kg
- •Documented allergy to study medications
- •Pain on injection of pre-operative normal saline flush
- •Patient has received an opioid within 30 minutes prior to anesthesia induction
研究组 & 干预措施
Lidocaine premedication Group
The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
干预措施: Lidocaine (Drug)
Ondansetron premedication Group
The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
干预措施: Ondansetron (Drug)
结局指标
主要结局
Change in Motor score scale from baseline
时间窗: Baseline, during propofol injection (30 seconds)
Change in Motor score between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain.
Change in verbal rating scale (VRS) form baseline
时间窗: Baseline, during propofol injection (30 seconds)
Difference in total VRS between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain.
Verbal Rating Scale (VRS)
时间窗: Baseline, during propofol injection (30 seconds)
VRS will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no verbal indication of pain, 1 refers to purposeless moaning, 2 refers to explicit protest and 3 refers to screaming/crying of pain. Higher scores indicate a higher level of perceived pain/distress.
Motor Score Scale
时间窗: Baseline, during propofol injection (30 seconds)
Motor score scale will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no movement, 1 refers to slight hand withdrawal, 2 refers to marked withdrawal, rubbing, trying to tear off the line and 3 refers to general restlessness. Higher scores indicate a more severe motor withdrawal response and higher perceived pain or distress.
次要结局
未报告次要终点
研究者
Vipin Bansal
Assistant Professor
Emory University