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临床试验/NCT03157882
NCT03157882终止不适用

Pediatric Pain Assessment in the Emergency Department

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
46
试验地点
1
主要终点
Faces Pain Scale - Revised (FPS-R)

研究概览

简要总结

To examine pediatric pain assessment in the Emergency Department

详细描述

Phase 1 is a qualitative assessment of how pain is currently evaluated in the pediatric Emergency Department (ED). Initial triage encounters will be observed and audio recorded. In addition to determining how often the Wong Baker FACES Pain Rating Scale (WBF) is administered with the intended script, the investigators will determine if there are common variations from the recommended script. The investigators will also evaluate how often a caregiver's perception of the child's pain is considered when completing the WBF.

Phase 2 is a quantitative assessment to determine if neurocognitive development impacts the responsivity of the WBF and the Faces Pain Scale - Revised (FPS-R) as well as the cognitive age equivalent required to use these scales accurately. Patients presenting with acute pain will report their level of pain before and after analgesic intervention using both the WBF and the FPS-R. They will also subjectively report their change in pain following analgesic intervention. Once the patient's pain has improved, he/she will complete the BRIGANCE Early Childhood Screens III to determine his/her cognitive age equivalent. He/she will also complete a series of tasks aimed to assess ability to successfully use the WBF and FPS-R (matching, grouping, classification, and seriation skills). The results of the child's self-report of pain will also be compared to the caregiver's estimate of the child's pain.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • verbal patients
  • pain score ≥ 6/10
  • caregiver speaks English or Spanish

排除标准

  • altered mental status
  • history of traumatic brain injury (TBI)
  • history of developmental delay
  • history of Autism
  • history of chronic pain, defined as persistent or recurrent pain in children with chronic health conditions
  • non-verbal patients

结局指标

主要结局

Faces Pain Scale - Revised (FPS-R)

时间窗: One day

The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Change in pain scale response before and after analgesic intervention that correlates with a subjective description of change in pain (better or worse).

Wong-Baker FACES ® Pain Rating Scale (WBF)

时间窗: One day

The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Change in pain scale response before and after analgesic intervention that correlates with a subjective description of change in pain (better or worse).

Qualitative Assessment (Phase 1 - Primary Aim)

时间窗: One day

Adherence to a validated script for pain scale administration (dichotomous value - yes/no)

次要结局

  • Convergent reliability between WBF and FPS-R (Phase 2 Secondary Aim #1)(One day)
  • Pre and Post Analgesia Pain Scores Using WBF and FPS-R as Reported by Patients and Caregivers(One day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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