What is this study trying to find out about acute pain in children and adolescents?

This study is evaluating how a new non-invasive device called the AlgometRx Nociometer can measure acute pain and responses to pain treatment more objectively in young patients. Researchers want to improve pain assessment methods beyond traditional self-report or observation. The study is sponsored by the Children's National Research Institute and aims to help future pediatric pain care.

Who may be eligible for this acute pain clinical trial?

Children and adolescents aged 6 to 21 years undergoing elective surgery or bone marrow transplantation may be eligible. Participants should not have a history of chronic pain before surgery and must be able to provide assent with parental permission. Please review eligibility criteria for more details.

Is there any cost to participate in this acute pain clinical trial?

Study-related care, including the use of the AlgometRx Nociometer and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 6Years - 21Years

All Genders

ID07336264

Measuring Acute Pain and Response to Treatment in Children and Adolescents Using a New Non-Invasive Device

Led by Children's National Research Institute · Updated on 2026-01-14

100

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying how acute pain and responses to pain treatment can be measured in children and adolescents using a non-invasive device. This trial focuses on pediatric patients aged 6 to 21 years undergoing elective surgery or bone marrow transplantation. Traditional pain assessments rely on self-report or observation, which can be challenging, so this study evaluates a new device called the AlgometRx Nociometer for more objective pain measurement. The AlgometRx Nociometer uses gentle electrical stimulation and measures pupil size changes to detect activity in pain-related nerve pathways. Participants will have measurements taken before and after their procedures and during routine hospital care. The device is used only for research purposes and does not affect medical treatment, which follows standard clinical care. This is an observational study without any study treatments. Participants will be monitored over up to 9 weeks, with pain measurements recorded alongside standard assessments. Researchers will collect data during hospital stays and follow-up visits. The main outcome is the Nociceptive Index measured from baseline through follow-up. Participation involves no changes to pain management, and the findings may help improve future pain assessment and treatment for children and adolescents.

CONDITIONS

Brief Title

Characterization of Acute Pain

Who Can Participate

Age: 6Years - 21Years

All Genders

Eligibility Criteria

You may qualify if you...

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
Able to provide written informed assent and parental permission/consent, as applicable

You will not qualify if you...

Documented history of eye disease that prevents pupil measurement
Unwilling or unable to participate in the study procedures or provide consent/assent

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Baseline period (day of procedure)

Participants undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline alongside standard clinical pain assessments before their elective surgical procedure or bone marrow transplant.

1 visit (in-person) before procedure

Post-operative Follow-up

Duration - Up to 9 weeks after procedure

Participants have postoperative follow-up visits during which nociceptive measurements and clinical pain assessments are performed alongside their standard clinical care.

Multiple visits during up to 9 weeks of follow-up