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Not yet recruiting NCT07145762

Analgesia Nociception Index In Pediatric Patients With Chronic Pain

Observational Chronic 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: Interventional Block.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: 9 years — 17 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
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Procedure 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.

Primary outcome measures

  • 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]

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.

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

Canada · 1 center
  • McGill University Health Centre — Montreal

Identifiers

NCT: NCT07145762 · ANI Project

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗