Analgesia Nociception Index In Pediatric Patients With Chronic Pain

NCT07145762 | Not Yet Recruiting

• 1 other identifier: ANI Project
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the analgesia nociceptive index (ANI) is associated with pain sensitivity in patients between the ages of 9-17 who are experiencing chronic pain. The main question it aims to answer is: \- Does the ANI score correlate with the change in the pain sensitivity in patients aged 9-17 undergoing an interventional block. Patients already receiving an interventional block as part of their regular medical care for chronic pain will have their level of pain recorded during clinic appointments

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Validation of analgesia nociception index (ANI) as a tool to assess change in the pain pressure threshold (PTT), measured by the PPT test, of children with chronic pain conditions.

  6 weeks

Study Arms (1)

Chronic pain patients receiving Interventional block

Procedure: Interventional Block

Interventions

Interventional Block PROCEDURE

For patients who are offered interventional blocks as part of their standard of care, we will measure ANI as well as pressure pain threshold before, during, and after the block as well and at follow-up to assess correlation with treatment efficacy.

Chronic pain patients receiving Interventional block

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are offered an interventional block at the Edwards Family Interdisciplinary Center for Complex Pain of the Montreal Children's Hospital will be invited to participate. Initial contact will be through the medical team in contact with the patient. They will ask them if they agree to be contacted for a research study. Once the patient consents to be contacted, the research coordinators will reach out the patient and explain the study.

You may qualify if:

• Experiencing chronic pain defined by: persistent or recurrent pain at least once a week for at least three months in their electronic medical charts or by reference of the patient's physician

You may not qualify if:

• Taking medications known to affect the sympathetic or parasympathetic nervous systems such as cholinomimetics (e.g., pilocarpine), anticholinergics (e.g., ipratropium), sympathomimetics (e.g., salbutamol), and adrenergic antagonists (e.g., propranolol).
• Diagnosed cardiac or neurological conditions, including patients with arrhythmias, heart block, postural orthostatic tachycardia syndrome, Guillain-Barre syndrome, or spinal cord injury.
• Active cancer diagnosis
• Conditions that may interfere with the ability to understand instructions or complete assessments including: cognitive, or developmental delay.
• Patients who do not speak English or French.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabrina Carrie, MD

CONTACT

514-412-4400; sabrina.carrie@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthetist

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)