The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Hourly Pain Scores
研究概览
简要总结
This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.
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
- Single (Care Provider)
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
- •Adults undergoing intracranial surgery
排除标准
- •Patient refusal
- •Pregnancy
- •Respiratory failure
- •Allergy/intolerance to fentanyl
- •Opioids use
- •History of opioid-dependent pain,
- •Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
- •Mental or physical limitations that would prevent patient assessment or PCA use
- •Chronic painful conditions unrelated to the reason for surgery,
- •Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
- •Patient is unable to initiate a bolus dose of IVPCA fentanyl
研究组 & 干预措施
Supratentorial PCA fentanyl
干预措施: PCA fentanyl (Drug)
Supratentorial PRN fentanyl
干预措施: PRN fentanyl (Drug)
Infratentorial PCA fentanyl
干预措施: PCA fentanyl (Drug)
Infratentorial PRN fentanyl
干预措施: PRN fentanyl (Drug)
结局指标
主要结局
Hourly Pain Scores
时间窗: Up to 16 hours
Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)
次要结局
- Fentanyl Consumption(Up to 16 hours)