Methadone in Ambulatory Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative Opioid Administration
研究概览
简要总结
The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
- •Signed, written, informed consent
排除标准
- •History of or known liver or kidney disease.
- •Females who are pregnant or nursing.
- •Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
- •History of allergy to methadone
研究组 & 干预措施
Treatment methadone 0.1 mg/kg
methadone 0.1 mg/kg
干预措施: methadone (Drug)
Control
Control (Intra-operative administration of opioids, other than methadone)
干预措施: Control (Intra-operative administration of opioids, other than methadone) (Drug)
Treatment methadone 0.15 mg/kg
干预措施: methadone (Drug)
结局指标
主要结局
Intraoperative Opioid Administration
时间窗: Administered at induction of anesthesia
Data on opioids administered intraoperatively will be collected from the subject's EMR.
Postoperative Opioid Administration
时间窗: EMR reviewed at 24 hours post-administration or at hospital discharge
Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale \[0-no relief, 4-complete relief\]
次要结局
- Opioid Consumption Within First 30 Postoperative Days(30 days)
- Pain Relief Within First 30 Postoperative Days(30 days)