Characterization of Acute Pain

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT07336264
Status
Recruiting
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Conditions

  • Acute Pain
  • Acute Pain, Postoperative
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
6 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • AlgometRx Nociometer — DEVICE
    The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions,

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Jan 2026
Primary completion
Dec 2, 2027
Completion
Jun 2, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Nociceptive Index [ Time Frame: Baseline through up to 9 weeks of follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Julia Finkel, M.D
[email protected]
2202-841-0362
Julia Finkel, M.D (PRINCIPAL_INVESTIGATOR)

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