NCT01823497已完成不适用
Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Morphine Consumption
研究概览
简要总结
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.
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
- 1 Minute 至 70 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery Location:
- •Abdominal or Thoracic
- •First surgery only
- •Born ≥ 34-44 weeks post-menstrual age
- •Weight: Weight at birth or current weight ≥2 kg Intubated or extubated
- •Prior opioid exposure:
- •< 2 days of continuous exposure
- •if history of > 2 day continuous exposure, must be off continuous drip for a week
- •Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero *In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.
- •At least 1 parent is English-speaking
排除标准
- •Surgery Type:
- •Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)
- •Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
研究组 & 干预措施
Parent/Nurse Controlled Analgesia
Active Comparator
Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
干预措施: Morphine (Drug)
Continuous Opioid Infusion
Active Comparator
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
干预措施: Morphine (Drug)
结局指标
主要结局
Morphine Consumption
时间窗: 5 days post surgery
The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour
次要结局
- Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale(4 days post surgery)
研究者
研究点 (1)
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