Efficacy of Neurostimulation on Opiate Withdrawal Symptoms in Pediatric ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Withdrawal Assessment Tool (WAT-1) Score
研究概览
简要总结
This is a prospective pilot study to investigate the effects of Percutaneous Electrical Nerve Field Stimulation (PENFS) on symptoms of opioid withdrawal in pediatric patients in the intensive care unit.
详细描述
This is a prospective, unblinded, randomized controlled pilot trial to evaluate the impact of the BRIDGE device when used on patients at high risk of opioid withdrawal following opioid exposure.
The investigator team hypothesized that treatment of pediatric intensive care unit (PICU) patients (ages 5-17 years) with PENFS will prevent the development of opioid withdrawal symptoms, reduce the need for long-acting opioid agonists or pharmacological rescue agents to treat withdrawal, and decrease overall PICU length of stay (LOS).
Aim 1: Withdrawal, using the Withdrawal Assessment Tool (WAT-I) is less for those using PENFS device than for those receiving standard of care (SOC) treatment.
H1: The WAT-I will be lower in the PENFS group than the SOC group and this will be true, even after adjusting for age and total opioid dose/kg pre-weaning.
Aim 2: For withdrawal symptoms of nausea, vomiting or pain, those receiving PENFS compared to SOC will require less treatment for these symptoms.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5 to 17 years
- •Admission to PICU at Children's Hospital of Wisconsin (CHW)
- •Exposure to at least 120 hours of continuous IV opioid administration.
排除标准
- •Age children <5 years
- •Known central nervous system injury (hypoxic ischemic injury, traumatic brain injury, postoperative craniotomies),
- •Plan to wean benzodiazepine dosing during the active study period
- •Patients who are developmentally delayed
- •o Defined as inappropriately non-verbal for age and determined through review of the medical record and discussion with the PICU attending and consulting team members.
- •Known pregnancy
- •o Any pregnancy testing done during the subject's hospitalization will be reviewed. This will only be monitored if required as SOC, but will not be collected for the purpose of the study alone.
- •Known seizure disorder
- •Known diagnosis of psoriasis or significant dermatological disease involving ear (?)
- •Patients with implantable devices (cardiac pacemaker, vagal nerve stimulator, etc.)
研究组 & 干预措施
Intervention Group
50% of subjects will be randomized to the Intervention group and will receive percutaneous electric nerve field stimulation (PENFS) through the BRIDGE Device for 120 hours to treat withdrawal symptoms in patients following opiate exposure in the PICU.
干预措施: Percutaneous Electrical Nerve Field Stimulation (Device)
Standard of Care Group
50% of subjects will be randomized to the Standard of Care group and will receive be started on the standardized PICU Methadone wean for patients following opiate exposure in the PICU.
结局指标
主要结局
Withdrawal Assessment Tool (WAT-1) Score
时间窗: Study Day 0 through Study Day 5
Measurement of opiate withdrawal symptoms experienced by study subjects
次要结局
- Pain Medication Use(Study Day 0 through Study Day 5)
- Pain Scores(Study Day 0 through Study Day 5)
- Length of Stay(PICU Admission)
研究者
Karen Marcdante
Principal Investigator
Medical College of Wisconsin