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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-29

Study Completion Date

2023-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Pediatric ALL

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Intensive Care Units, Pain Measurement ANI, Analgesia Nociception Index Pediatric,

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

case group

children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Non sinusal rythm
* Atropine
* Pace-macker

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morgan RECHER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Barat A, Wojtanowski A, Behal H, Flocteil M, Leteurtre S, De Jonckheere J, Recher M. Evaluation of the Analgesia Nociception Index (ANI) as an indicator of discomfort in deeply sedated, prepubescent patients. J Clin Monit Comput. 2025 Sep 9. doi: 10.1007/s10877-025-01355-2. Online ahead of print.

Reference Type DERIVED

PMID: 40924276 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A00487-34

Identifier Type: OTHER

Identifier Source: secondary_id

2020_92

Identifier Type: -

Identifier Source: org_study_id