Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Average Postoperative Pain Score
研究概览
简要总结
Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain > 6 months
- •Long term use of opioids
- •Major surgery
排除标准
- •Use of regional anesthetic techniques
- •No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
研究组 & 干预措施
Ketamine
Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
干预措施: Ketamine (Drug)
Ketamine
Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
干预措施: Hydromorphone PCA (Drug)
Placebo
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
干预措施: Placebo (Drug)
Placebo
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
干预措施: Hydromorphone PCA (Drug)
结局指标
主要结局
Average Postoperative Pain Score
时间窗: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.
次要结局
- 24-Hour Postoperative Opioid Use(For 24 hours following surgery)
- Worst Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
- Least Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
- Number of Participants With Treatment Related Adverse Events (AEs)(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
研究者
Srdjan Nedeljkovic
Staff, Pain Management Center
Brigham and Women's Hospital