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临床试验/NCT07336264
NCT07336264招募中不适用

Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients

Children's National Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Nociceptive Index

研究概览

简要总结

This study aims to better understand how acute pain and responses to pain treatment can be measured in children and adolescents using a non-invasive device. Pain is usually assessed using self-reported or observational scales, which can be difficult to interpret, especially in pediatric patients. This study will evaluate whether a novel device, the AlgometRx Nociometer, can provide an objective measure of nociceptive pain. Participants ages 6 to 21 years who are undergoing elective surgery or bone marrow transplantation will be enrolled at Children's National Hospital. The device measures changes in pupil size in response to gentle electrical stimulation, which reflects activity in pain-related nerve pathways. Measurements will be taken before and after procedures and during routine hospital care, alongside standard pain assessments. This is an observational study. Participation will not change or guide any medical treatment, and all pain management will follow standard clinical care. The information collected may help improve future pain assessment and treatment for pediatric patients.

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
6 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents ages 6 to 21 years
  • Undergoing elective surgical procedures without a history of chronic pain, OR undergoing or planning to undergo bone marrow transplantation (BMT)
  • Able to provide written informed assent and parental permission/consent, as applicable

排除标准

  • Documented history of eye disease that precludes pupillometry
  • Unwilling or unable to participate

研究组 & 干预措施

Surgical Cohort

Children and adolescents ages 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain prior to surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow standard of care and will not be influenced by study participation.

干预措施: AlgometRx Nociometer (Device)

Bone Marrow Transplant (BMT) Cohort

Children and adolescents aged 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain before surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow the standard of care and will not be influenced by study participation.

干预措施: AlgometRx Nociometer (Device)

结局指标

主要结局

Nociceptive Index

时间窗: Baseline through up to 9 weeks of follow-up

The nociceptive index calculated from neuroselective stimulus-induced pupillary reflex dilation (nPRD) measurements obtained using the AlgometRx Nociometer. The index is derived from the area under the curve (AUC) of pupillary dilation responses corresponding to selective activation of sensory nerve fiber types and is used to characterize acute nociceptive pain.

次要结局

未报告次要终点

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Finkel

Vice chief for Pain Medicine and Research

Children's National Research Institute

研究点 (1)

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