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临床试验/NCT03794362
NCT03794362招募中不适用

Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study

Julia Finkel1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Pupillary Reflex Dilation (PRD) Area under Curve (AUC)

研究概览

简要总结

It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.

研究设计

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

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The subject is 7 to 21 years of age
  • •The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
  • •The subject is willing and able to provide written informed assent/parental consent to the study participation.

排除标准

  • •Eye pathology precluding pupillometry
  • •Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
  • •Subjects who are or may be pregnant

结局指标

主要结局

Pupillary Reflex Dilation (PRD) Area under Curve (AUC)

时间窗: 0, 15, 30, 45, 60, 90, 120, 180 minutes

The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.

次要结局

  • Pupillary Light Reflex (PLR) Recovery Time(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Reflex Dilation (PRD) Amplitude(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Light Reflex (PLR) Latency(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Light Reflex (PLR) Amplitude(0, 15, 30, 45, 60, 90, 120, 180 minutes)

研究者

发起方
Julia Finkel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julia Finkel

Principal Investigator

Children's National Research Institute

研究点 (1)

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