跳至主要内容
临床试验/NCT02456909
NCT02456909已完成不适用

The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Patient Satisfaction Questionnaire

研究概览

简要总结

To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.

详细描述

Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest PCA pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. No studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 7-18 years
  • Opioid naïve
  • Scheduled for a surgery for which a PCA is routinely used for post-operative pain management
  • At least 1 parent speaks English

排除标准

  • Prior experience with PCA
  • Cognitive delay precluding independent use of the PCA button
  • Current use of anxiolytics or antidepressants
  • Patients receiving epidural analgesia

研究组 & 干预措施

Cues

Experimental

The PCA pump will be programmed to provide a cue to the end of the lockout period.

干预措施: Patient-Controlled Analgesia pump with Cues (Device)

Cues

Experimental

The PCA pump will be programmed to provide a cue to the end of the lockout period.

干预措施: Morphine (Drug)

No Cues

Placebo Comparator

The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).

干预措施: Patient-Controlled Analgesia pump without Cues (Device)

No Cues

Placebo Comparator

The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).

干预措施: Morphine (Drug)

结局指标

主要结局

Patient Satisfaction Questionnaire

时间窗: Up to 72 hours

Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.

次要结局

  • Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)(Post-op Days [POD] 0 - 2, up to 72 hours)
  • Anxiety (State Anxiety on POD 1 and POD 2)(Up to 72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keri Hainsworth

Associate Professor

Medical College of Wisconsin

研究点 (1)

Loading locations...

相似试验