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NCT Number: NCT07145762

Analgesia Nociception Index In Pediatric Patients With Chronic Pain

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

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Carrie, MD

CONTACT

[email protected]

514-412-4400 ext. 24884

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Validity of the Analgesia Nociception Index in Children and Adolescents With Chronic Pain

Acronym: Chronic pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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