Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Post-operative Opioid Consumption (mg/kg)
研究概览
简要总结
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.
Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.
详细描述
This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-18 years
- •Idiopathic scoliosis
- •Fusion levels planned for 10 or greater
- •English speaking
- •American Society of Anesthesiology (ASA) class 1 - 3
排除标准
- •Current narcotic use / History of substance use disorder
- •Morphine, hydromorphone or methadone allergies
- •Pregnancy
- •Seizure disorders
- •Bleeding disorders
- •Neuromuscular scoliosis
- •History of renal or hepatic disease
- •Long QT syndrome
- •Obstructive sleep apnea
- •Body mass index > 40
- •Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
- •Non-English speaking
研究组 & 干预措施
Methadone Group
Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
干预措施: Methadone (Drug)
Methadone Group
Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
干预措施: Morphine (Drug)
Control Group
Patient will receive normal saline placebo initially, then morphine prior to emergence.
干预措施: Normal Saline (Other)
Control Group
Patient will receive normal saline placebo initially, then morphine prior to emergence.
干预措施: Morphine (Drug)
结局指标
主要结局
Post-operative Opioid Consumption (mg/kg)
时间窗: 72 hours
Total amount of opioids consumed during the first 72 hours after surgery.
次要结局
未报告次要终点
研究者
Keri Hainsworth
Associate Professor
Medical College of Wisconsin