The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction of post-operative opioid induced constipation
研究概览
简要总结
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.
详细描述
Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.
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
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spinal fusion surgery
- •current opioid use
- •12 years of age and older
- •no or inadequate bowel movement by post-operative day 3
排除标准
- •known or expected mechanical bowel obstruction
- •known or suspected lesions of the GI tract
- •unexpected transfer to ICU
- •unexpected return to the operating room
- •patient or parent refusal of methylnaltrexone
- •incomplete data concerning time to laxation
研究组 & 干预措施
Study group
Weight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol.
干预措施: Methylnaltrexone (Drug)
Study group
Weight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol.
干预措施: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax (Drug)
Institutional bowel protocol
Patient will receive institutional standard bowel protocol. Beginning on post-operative day one either miralx,docusate sodium or senna, on a weight-based dose. If no bowel movement in 72 hours, either oral bisacodyl or magnesium hydroxide, on a weight-based dosing, will be added.
干预措施: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax (Drug)
结局指标
主要结局
reduction of post-operative opioid induced constipation
时间窗: first post-operative week
次要结局
- time to ambulation in post-operative pediatric spinal fusion patients(first post-operative week)
研究者
Deborah J. Vermaire MD
Anesthesiologist
Shriners Hospitals for Children