Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Noxious Stimuli Results
研究概览
简要总结
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation
详细描述
This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery.
The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants.
The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:
- •Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
- •Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade
- •Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
- •Patients who are not anticipated to receive acute post-surgical neuromuscular blockade
- •Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);
- •Group D No plan for surgery
排除标准
- •Confirmed or suspected clinical seizures
- •Metabolic abnormalities or inborn error of metabolism
- •Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes
结局指标
主要结局
Noxious Stimuli Results
时间窗: Up to 1 year
To assess pain-specific brain activity and autonomic responses post surgery in response to an acute noxious procedure in newborn infants admitted to the NICU. This outcome will be correlated with current behavioral and physiological based pain assessment tools as follows: Procedural-specific brain activity in infants with varying conditions with pre or post-operative pain. EEG: amplitude of noxious-event related potential evoked by a time-locked noxious stimulus. Pain-specific electro-dermal activity (EDA), electromyography (EMG) and subdermal skin flow; Pain-evoked behavioral measures including: Body movement; Eye squeeze, brow bulge and nasolabial furrow duration. Pain-evoked physiological measures including: Respiration rate; Heart rate; Blood pressure; Oxygen saturation; Observational pain scores (PIPP); EMG activity.
次要结局
- Resting State Results(Up to 1 year)
研究者
Laura Cornelissen PhD
PhD
Boston Children's Hospital