The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total IV Morphine Consumption up to 48 Hours Post Surgery
研究概览
简要总结
This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children.
Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.
详细描述
Up to 80 people from Denver will participate in the study. Subjects will be randomized to receive one of two possible medications during surgery to help with pain after surgery. After they go to sleep for surgery the anesthesiologist will give them either (1) a single injection of morphine into the spinal fluid in the lower back, or (2) a single injection of extended-release morphine into the epidural space (just outside the spinal fluid) in the lower back.
The usual care for patients having this surgery is a single injection of morphine into the spinal fluid in the lower back. If randomized to group (1), subjects will receive the usual care for pain control. If subjects are randomized to group (2), they will receive a single injection of extended-release morphine into the epidural space.
During surgery, a small blood sample (1 teaspoon or less) will be collected to analyze specific DNA sequences that are involved in individual responses to morphine for pain control. The blood sample will be destroyed after 24 months.
After surgery, subjects will have IV pain medication through a patient-controlled analgesia (PCA) machine. Subjects will be shown how to work the PCA so they can get the pain medicine when they need it. A research nurse will check in frequently to ask how much pain is occurring following the surgery and any side effects that may arise from the study medicine.
Subjects will be in this study up to 60 hours after surgery.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
- •Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.
排除标准
- •Neuromuscular scoliosis.
- •A history of documented coagulopathy or platelet count of less than 100,000 mm
- •A known allergy or adverse sensitivity to morphine.
- •Pulmonary hypertension or other significant respiratory problem.
- •Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
- •History of sleep apnea defined by sleep study and/or need for nighttime CPAP.
- •Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).
- •Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).
- •Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.
- •Need for preoperative intravenous inotropic drugs.
- •Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.
- •A contraindication to dural puncture, such as raised intracranial pressure.
- •Pre-operative heparin, oral aspirin or anticoagulants.
- •Weight less than 20kg or greater than 100kg.
- •Need for Intraoperative ketamine administration.
研究组 & 干预措施
Intrathecal morphine
Receives a single dose of intrathecal morphine
干预措施: Intrathecal morphine (Drug)
Extended Release Epidural Morphine
Receives DepoDur extended release epidural morphine for pain management
干预措施: Extended Release Epidural Morphine (Drug)
结局指标
主要结局
Total IV Morphine Consumption up to 48 Hours Post Surgery
时间窗: Four hour intervals for up to 48 hours
Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.
次要结局
- Adverse Opioid Effect: Respiratory Depression(every 4 hours up to 48 hours)
- Post-operative Pain Scores(every 4 hours up to 48 hours)
- Adverse Opioid Effect: Nausea(every 4 hours up to 48 hours)
- Adverse Opioid Effect: Emesis(every 4 hours up to 48 hours)
- Adverse Opioid Effect: Pruritus(every 4 hours up to 48 hours)
- Time Until First PCA Demand Request(every 4 hours up to 48 hours)