Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Amount of Morphine Consumed (mg/kg/hr)
研究概览
简要总结
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).
详细描述
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine
No remifentanil, clonidine, ketamine
N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
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
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1-2, Idiopathic Scoliosis
排除标准
- •ASA 3 or greater
- •Neuromuscular scoliosis
- •On narcotics baseline
研究组 & 干预措施
2
Placebo Comparator -- pill matched in appearance to gabapentin
干预措施: Placebo (Drug)
1
Gabapentin
干预措施: Gabapentin (Drug)
1
Gabapentin
干预措施: Morphine (Drug)
2
Placebo Comparator -- pill matched in appearance to gabapentin
干预措施: Morphine (Drug)
结局指标
主要结局
Amount of Morphine Consumed (mg/kg/hr)
时间窗: Day 2
次要结局
- Number of Ondansetron Doses Administered for Nausea(First 10 days after surgery)
研究者
Lynn Rusy
Professor of Anesthesiology
Medical College of Wisconsin