Effect of Early Administration of Morphine on the Development of Acute Opioid Tolerance During Infusion of Remifentanil for Pediatric Scoliosis Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
The purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery.
详细描述
At our institution, a study has recently demonstrated that intraoperative infusion of remifentanil is associated with development of clinically relevant acute opioid tolerance in adolescents undergoing scoliosis surgery. This results in increased morphine consumption which in turn is associated with increased incidence of side effects such as respiratory depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side effects can result in increased consumption of rescue medications with the additional potential for increased duration of patient stay. Any measures that can be introduced to decrease the development of acute opioid tolerance in this patient population would have significant impact on patient morbidity, patient comfort and possibly duration of patient stay.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unpremedicated
- •ASA physical status 1 or 2
- •Aged 11 - 18
- •Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis
排除标准
- •Chronic opioid use within three months prior to surgery
- •Inability to self-administer morphine using a patient-controlled analgesia (PCA) device
- •Elective postoperative ventilation
- •Obesity (> 130% ideal body weight)
- •Known sensitivity to morphine, remifentanil or any other agent within the standardized protocol
- •Failure to obtain written consent or assent
研究组 & 干预措施
1
干预措施: Saline (Other)
2
干预措施: Morphine (Drug)
结局指标
主要结局
Morphine consumption
时间窗: Every hour for four hours and then every four hours thereafter for 48 hours
次要结局
- Propofol and remifentanil consumption(48 hours)
- Incidences of post-operative nausea, vomiting, pruritus and pyrexia(every hour for four hours and then every four hours thereafter for 48 hours)
研究者
Mark Crawford
Anesthesiologist-In-Chief
The Hospital for Sick Children