Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Total Amount of Opioid Medications Administered
研究概览
简要总结
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery.
详细描述
This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 3 to 17 years old
- •Presenting for elective tonsillectomy +/- adenoidectomy
- •Provide informed consent / assent (as appropriate)
排除标准
- •History of liver or kidney disease
- •Females with positive pregnancy test
- •Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
- •Consistent daily opioid use for chronic pain ( >3 months)
研究组 & 干预措施
Short acting opioids: Fentanyl, Hydromorphone
干预措施: Fentanyl/Hydromorphone (Drug)
Long Acting Opioid: Methadone
干预措施: Methadone (Drug)
结局指标
主要结局
Total Amount of Opioid Medications Administered
时间窗: Up to 7 days post surgery
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
次要结局
- Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain(Up to 7 days post surgery)
- NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale(Up to 7 days post surgery)
- Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale(Up to 7 days post surgery)
- Doses of Prescription Opioid Used Following Hospital Discharge(Up to 7 days post surgery)
- Opioid Administration in the PACU (Post-anesthesia Care Unit)(Up to 6 hours post surgery)