The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- change in pain intensity
研究概览
简要总结
An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.
Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.
The following hypotheses were tested:
- The application of additional opiate boli results in significantly lower pain intensity.
- The application of additional opiate boli does not result in a higher rate of adverse Events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic pain syndrome
- •intrathecal opiate pump
- •signed informed consent
排除标准
- •younger than 18 years
- •other (than opiate) intrathecal drug administration
- •discontent with intrathecal opiate therapy
研究组 & 干预措施
opiate without bolus
continuous opiate administration without bolus application
干预措施: opiate with bolus (Drug)
opiate with bolus
continuous opiate administration with additional bolus application
干预措施: opiate with bolus (Drug)
结局指标
主要结局
change in pain intensity
时间窗: day 0. day 14, day 28
numeric rating scale from 0 to10
次要结局
- change in satisfaction with treatment outcome(day 0, day 14, day 28)
- side effects(from day 0 to day 28)