Characterization of Acute Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AlgometRx Nociometer.
- Who it may be relevant to
- Registry conditions: Acute Pain, Postoperative, Postoperative Pain, Acute Pain. Basic parameters: 6 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
Overview
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.
Interventions
- Device AlgometRx Nociometer
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,
Primary outcome measures
- Nociceptive Index [Time frame: Baseline through up to 9 weeks of follow-up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Documented history of eye disease that precludes pupillometry
- Unwilling or unable to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Publications
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
- Instrument: PROMIS Pain Intensity - Short Form 3a v1.0 | NIDA CTN Common Data Elements. https://cde.nida.nih.gov/instrument/0a481bfb-a5e6-3c84-e050-bb89ad43314d
- Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15. PMID 22424915
- Wong-Baker FACES® Pain Rating Scale. (2016)
- Lavoie Smith EM, Li L, Hutchinson RJ, Ho R, Burnette WB, Wells E, Bridges C, Renbarger J. Measuring vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia. Cancer Nurs. 2013 Sep-Oct;36(5):E49-60. doi: 10.1097/NCC.0b013e318299ad23. PMID 23842524
- Barr MS, Farzan F, Davis KD, Fitzgerald PB, Daskalakis ZJ. Measuring GABAergic inhibitory activity with TMS-EEG and its potential clinical application for chronic pain. J Neuroimmune Pharmacol. 2013 Jun;8(3):535-46. doi: 10.1007/s11481-012-9383-y. Epub 2012 Jun 29. PMID 22744222
- Chouchou F, Perchet C, Garcia-Larrea L. EEG changes reflecting pain: is alpha suppression better than gamma enhancement? Neurophysiol Clin. 2021 Jun;51(3):209-218. doi: 10.1016/j.neucli.2021.03.001. Epub 2021 Mar 16. PMID 33741256
- Crawford L, Mills E, Meylakh N, Macey PM, Macefield VG, Henderson LA. Brain activity changes associated with pain perception variability. Cereb Cortex. 2023 Mar 21;33(7):4145-4155. doi: 10.1093/cercor/bhac332. PMID 36069972
Identifiers
NCT: NCT07336264 · STUDY00001386 · STUDY00001386