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临床试验/NCT02352116
NCT02352116招募中不适用

Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients

Columbia University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Change in Postoperative Pain Measure for Parents Score

研究概览

简要总结

This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.

详细描述

With the increased frequency and popularity of pediatric ambulatory surgery, there is a greater need for evaluation of the postoperative pain experience after discharge from the hospital. Pain is one of the most significant factors affecting the postoperative experience in adults, and also be true in the pediatric population. Control of postoperative pain in children after discharge from the hospital poses particular challenges due to dependence on parental or caretaker ability to properly evaluate the child's pain, their understanding of appropriate dosing of pain medications, and their willingness to administer enough medications until sufficient relief is achieved.

The investigators aim to assess the differences in reported pain between groups who receive additional face-to-face education versus the current standard of care at a major US teaching hospital. The study will assess pain management after surgery using parental reports and questionnaires to assess their child's pain at multiple time points during the study. Additionally, this study will also assess baseline behavioral attributes of children and will compare behavioral changes at 24-48 hours, 7-10 days, and 2-4 weeks postoperatively as these behavior changes may also affect overall postoperative experience.

This study is divided into phase I and phase II. Phase I is the initial assessment of the investigators' institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures. Phase II consists of randomized trial which includes a randomized intervention group and control group. The group selected randomly for intervention will receive additional teaching regarding what to expect in terms of postoperative pain and how to properly identify pain in children.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients ages 1-6 years undergoing ambulatory surgical procedures.
  • Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.

排除标准

  • Patients with an ASA status of III or IV.
  • Patients admitted as inpatients or transferred to the PICU or inpatient for recovery, and any conditions that may affect pain expression or sensation.

研究组 & 干预措施

Additional education

Experimental

Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.

干预措施: Additional face-to-face education (Other)

Additional education

Experimental

Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.

干预措施: Standard of care management (Other)

No additional education

Active Comparator

Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management.

干预措施: Standard of care management (Other)

结局指标

主要结局

Change in Postoperative Pain Measure for Parents Score

时间窗: baseline, 72 hours, 7-14 days, up to 4 weeks

Validated questionnaire for parental assessment of pain in children ages 1-12 years

次要结局

  • Change in Postoperative Anesthesia Emergence Delirium (PAED) Score(baseline, 72 hours, 7-14 days, up to 4 weeks)
  • Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale(baseline, 72 hours, 7-14 days, up to 4 weeks)
  • Change in Modified Yale Preoperative Anxiety Scale (mYPAS)(baseline, 72 hours, 7-14 days, up to 4 weeks)
  • Change in Post-Hospital Behavior Questionnaire Score(baseline, 72 hours, 7-14 days, up to 4 weeks)

研究者

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

Lena S. Sun

Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics

Columbia University

研究点 (1)

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