Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- PCoA™ Acute safety
研究概览
简要总结
Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operative procedure with at least 3 days' hospital stay.
- •Planned post-operative pain therapy with oral medication using a strong opioid.
- •No contra-indication for opioid therapy.
- •No contra-indication for oral pain therapy.
- •Patient was able to understand and complete the questionnaire.
- •Patient signed an informed consent form.
排除标准
- •Opioid or drug addiction.
- •Opioid intolerance.
- •Pain therapy using IV PCA or infusion.
- •Rejection of opioid therapy.
- •Not able to swallow medicine.
结局指标
主要结局
PCoA™ Acute safety
时间窗: 48 hr
No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
PCoA™ Acute efficacy
时间窗: 48hr
Success rate of 90% for pill intake upon patient's request, No critical device malfunction, Time of pill intake reduced by at least 50% in the test group compared to the control group
PCoA™ Acute usability
时间窗: 48hr
At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues
次要结局
- Number of pill intakes during the study(48hr)