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Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance

Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance: Interest of Pain Hetero-assessment by Coupling ANI-HRV-scales : ANI-DOL Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02769598
Acronym
ANI-DOL
Enrollment
30
Registered
2016-05-11
Start date
2016-07-31
Completion date
2016-12-31
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Hospitalized, Children, Pain Measurement

Keywords

Pain, Nociception, Pediatric intensive care, Pain assessment scale, ANI index

Brief summary

Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides. Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain. The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. The caregiver will have the opportunity to fine tune the effective treatment.

Detailed description

Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides. Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). It is based on the study of the variability of the heart rate control changes in sympathetic and parasympathetic systems in response to stimuli. Clinical correlations have been completed for most of adult patients during or after general anesthesia. The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain. The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. This study is based on a real-time analysis of the perception of pain in children. It is a critical validation step that could dramatically change the treatment of pediatric patients in intensive care and pediatric intensive care units by facilitating real-time patient management. The caregiver will have the opportunity to fine tune the effective treatment. The validation of this stool will allow the pain measure for children highly sedated or presenting a neuromotor handicap.

Interventions

DEVICEANI Index for Hospitalized children

Each file consists of a simultaneous recording of an ECG signal, according to usual practice, coupled with a record of ANI Index (Analgesia Nociception Index) by MetroDoloris®. The ECG signals and the ANI index are recorded simultaneously on a computer.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

\- Children hospitalized in pediatric intensive-care unit of the University Hospital of Saint-Etienne, painful and receiving analgesic treatment of level 2 or 3.

Exclusion criteria

* Children in therapy or neurological coma, * Children enjoying a treatment known to change the ortho or parasympathetic system.

Design outcomes

Primary

MeasureTime frameDescription
ANI Index24 hoursANI Index will be measured during 24 hours and coated from 0 to 100 to have an idea of the patient's pain. It will also be compared to the FLACC Score (Face-Legs-Activity-Cry-Consolability Score) that is routinely measured and coated from 0 to 10.

Secondary

MeasureTime frameDescription
Ptot24 hoursPtot is a cardiac frequency variability index and it will be measured at 24 hours.
VLF24 hoursVLF (Very Low Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
LF24 hoursLF (Low frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
HF24 hoursHF (High Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
HFnu Index24 hoursHigh Standard Frequency Index (HFnu) of Short Term RR variability in heart rate (HRV) in the frequency domain will be measured at 24 hours.
SDNN24 hoursSDNN (Standard Deviation of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
SDANN24 hoursSDANN (Standard Deviation of the Averages of NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
pNN5024 hourspNN50 (NN50 count divided by the total number of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
LF/HF Ratio24 hoursLF (Low Frequencies) / HF (High Frequencies) Ratio is a cardiac frequency variability index and it will be measured at 24 hours.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026