Pain assessment: global use of the Brief Pain Inventory.
C S Cleeland, K M Ryan
https://pubmed.ncbi.nlm.nih.gov/8080219Actively Recruiting
Age: 6Years - 21Years
All Genders
ID07336264
Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
Led by Children's National Research Institute · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
V
VentureWell
Collaborating Sponsor
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Loading map...
Research Team
J
Julia Finkel, M.D
S
Shaghayegh Rezalou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time.
M Gabrielle Pagé, Joel Katz, Jennifer Stinson...
https://pubmed.ncbi.nlm.nih.gov/22424915Measuring vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia.
Ellen M Lavoie Smith, Lang Li, Raymond J Hutchinson...
https://pubmed.ncbi.nlm.nih.gov/23842524Measuring GABAergic inhibitory activity with TMS-EEG and its potential clinical application for chronic pain.
Mera S Barr, Faranak Farzan, Karen D Davis...
https://pubmed.ncbi.nlm.nih.gov/22744222EEG changes reflecting pain: is alpha suppression better than gamma enhancement?
Florian Chouchou, Caroline Perchet, Luis Garcia-Larrea
https://pubmed.ncbi.nlm.nih.gov/33741256Brain activity changes associated with pain perception variability.
L Crawford, E Mills, N Meylakh...
https://pubmed.ncbi.nlm.nih.gov/36069972MRI grading of spinal stenosis is not associated with the severity of low back pain in patients with lumbar spinal stenosis.
Masakazu Minetama, Mamoru Kawakami, Masatoshi Teraguchi...
https://pubmed.ncbi.nlm.nih.gov/36096768Functional MRI and pain.
Kenneth Fomberstein, Saeeda Qadri, Ramachandran Ramani
https://pubmed.ncbi.nlm.nih.gov/23995063