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

Pain Clinical Trial

— ANI-EP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913038
• Other study ID #: 2020_92
• Secondary ID: 2021-A00487-34
• Status: Recruiting
• Start date: June 29, 2021
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Morgan RECHER, MD
• Phone: 0320445962
• Email: morgan.recher[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non sinusal rythm

• Atropine

• Pace-macker

Related Conditions & MeSH terms

• Pain
• Pediatric ALL

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia Nociception Index (ANI) minimum		at 10 minutes before the painful care
Primary	ANI minimum		at 30 minutes (average lenght of painful care)
Primary	ANI minimum		at 10 minutes after the painful care
Secondary	Variation of ANI minimum between before and after a painful care		From 10 minutes before the care to 10 minutes after the care
Secondary	the correlation between ANI minimum and the COMFORT B behavioral scale.	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.	From 10 minutes before the care to 10 minutes after the care
Secondary	the ability of ANI minimum to distingush painful from non painful patient		From 10 minutes before the care to 10 minutes after the care
Secondary	Area under the ROC curve of ANI min calculated over all measurements		From 10 minutes before the care to 10 minutes after the care