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OpenTrials
Completed

NCT Number: NCT04913038

Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.

The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.

In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.

To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.

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Key information

Conditions

Pain Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated

Exclusion criteria

  • Non sinusal rythm
  • Atropine
  • Pace-macker

Treatment and study plan

Primary outcomes

  1. Analgesia Nociception Index (ANI) minimum

    Time frame: at 10 minutes before the painful care

  2. ANI minimum

    Time frame: at 30 minutes (average lenght of painful care)

  3. ANI minimum

    Time frame: at 10 minutes after the painful care

Secondary outcomes

  1. Variation of ANI minimum between before and after a painful care

    Time frame: From 10 minutes before the care to 10 minutes after the care

  2. the correlation between ANI minimum and the COMFORT B behavioral scale.

    Time frame: From 10 minutes before the care to 10 minutes after the care

    The COMFORT BEHAVIOURAL (COMFORT-B) SCALE consists of six items: alertness, calmness, respiratory response, body movements, facial tension and muscle tone. Each item goes from 1 to 5, assessing the different intensities. The sum of the six ratings leads to a final score ranging from a minimum of 6 to a maximum of 30. A patient is considered to be under-sedated in case of COMFORT-B scores of 23 or higher, over-sedated in case of COMFORT-B scores of 10 or lower.

  3. the ability of ANI minimum to distingush painful from non painful patient

    Time frame: From 10 minutes before the care to 10 minutes after the care

  4. Area under the ROC curve of ANI min calculated over all measurements

    Time frame: From 10 minutes before the care to 10 minutes after the care

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.

Acronym: ANI-EP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2021
Registry last updated
Dec 19, 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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