Analgesic Effects of Gabapentin After Scoliosis Surgery in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Total morphine consumption postoperatively.
研究概览
简要总结
The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction.
详细描述
Surgical correction of scoliosis involves major orthopedic surgery, and can lead to severe acute postoperative pain and persistent neuropathic pain. The mainstays of treating postoperative pain are acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), systemic opioids, and local anesthetic techniques. Despite being effective, their use is limited by adverse side effects. Acute postoperative pain involves multiple mechanisms and neural pathways, therefore a combination of different analgestic medications acting through different mechanisms, may be the most effective treatment. This strategy may also reduce the need for, and side effects of, using high doses of any one particular class of drugs.
Gabapentin is safe and well tolerated with few side effects and has minimal interactions with other drugs. The use of gabapentin to treat acute postoperative pain may improve quality of analgesia, result in decreased requirements for opioids and might consequently reduce the incidence of opioid induced side effects. It may also have a direct effect on postoperative nausea and vomiting, and decrease the incidence of persistent neuropathic pain. These qualities make gabapentin an attractive agent for use in management of postoperative pain in children undergoing corrective spinal injury.
The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 - 17 years of age
- •scheduled for elective surgical correction of scoliosis
- •able to operate a patient-controlled analgesia (PCA) pump
排除标准
- •unable to cooperate
- •unable to operate the PCA pump
- •unable to rate pain
- •have a known allergy or sensitivity to gabapentin or morphine
- •have a history of chronic pain or daily analgesic use
- •have taken acetaminophen, a non-steroidal anti-inflammatory drug, or an antacid within a 24-hour period prior to surgery
研究组 & 干预措施
Gabapentin
Single dose preoperative gabapentin
干预措施: Gabapentin (Drug)
Placebo Control
Single dose preoperative placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Total morphine consumption postoperatively.
时间窗: 0 to 24 hours postoperatively
次要结局
- Time to first rescue analgesia.(Determined by outcome)
- Pain intensity scores at rest and with movement(Assessed at 1 hour, 4 hours, 12 hours, 24 hours, 72 hours, and 1 week postoperatively and at the 6-week outpatient follow up visit.)
- Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, and presence of persisting pain symptoms(Assessed at 1 hour, 4 hours, 12 hours, 24 hours, and 48 hours postoperatively.)
- Time to first postoperative oral intake as a measure of bowel function.(Determined by outcome)
研究者
Arie Peliowski
Staff Anesthesiologist
The Hospital for Sick Children