PainANI-EPNCT04913038
Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.
An observational study of Pain and Pediatric ALL, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain, Pediatric ALL
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2021to 23 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care
Who may be able to join
- Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated
Who cannot join
- Non sinusal rythm
- Atropine
- Pace-macker
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Pain, Pediatric ALL
- Keywords
- Intensive Care Units,, Pain Measurement, ANI, Analgesia Nociception Index, Pediatric,
- Medical subject headings
- Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia Nociception Index (ANI) minimum
Measured: at 10 minutes before the painful care
ANI minimum
Measured: at 30 minutes (average lenght of painful care)
ANI minimum
Measured: at 10 minutes after the painful care
Secondary outcomes (4)
Variation of ANI minimum between before and after a painful care
Measured: From 10 minutes before the care to 10 minutes after the care
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.
Measured: From 10 minutes before the care to 10 minutes after the care
the ability of ANI minimum to distingush painful from non painful patient
Measured: From 10 minutes before the care to 10 minutes after the care
Area under the ROC curve of ANI min calculated over all measurements
Measured: From 10 minutes before the care to 10 minutes after the care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start29 Jun 2021
- Primary completion22 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan RECHER, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913038
- Sponsor's protocol ID
- 2020_92
- Other IDs
- 2021-A00487-34
- Acronym
- ANI-EP
- Status last verified
- Nov 2023
- First submitted
- 17 May 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Feb;40(1):203-209. doi: 10.1007/s10877-025-01355-2. Epub 2025 Sep 9.
PubMed 40924276
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04913038
- Acronym / sponsor ID
- ANI-EP / 2020_92
- Conditions
- Pain, Pediatric ALL
- Keywords
- Intensive Care Units,, Pain Measurement, ANI, Analgesia Nociception Index, Pediatric,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case group | – | –children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care
Key inclusion criteria (1 listed)
- Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated
Key exclusion criteria (3 listed)
- Non sinusal rythm
- Atropine
- Pace-macker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analgesia Nociception Index (ANI) minimum
Time frame: at 10 minutes before the painful care
ANI minimum
Time frame: at 30 minutes (average lenght of painful care)
ANI minimum
Time frame: at 10 minutes after the painful care
4 secondary outcomes
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
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 40924276Barat 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. 2026 Feb;40(1):203-209. doi: 10.1007/s10877-025-01355-2. Epub 2025 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan RECHER, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pediatric ALL, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia Nociception Index (ANI) minimum (time frame: at 10 minutes before the painful care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.