Analgesia Nociception Index In Pediatric Patients With Chronic Pain

NCT ID: NCT07145762

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic pain patients receiving Interventional block

Interventional Block

Intervention Type: 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.

Interventions

Interventional Block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Sabrina Carrie

Pediatric Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Sabrina Carrie, MD

Role: CONTACT

sabrina.carrie@mcgill.ca

514-412-4400 ext. 24884

Other Identifiers

ANI Project

Identifier Type: -

Identifier Source: org_study_id