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Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance (ANI-DOL)

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

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Saint Etienne, Frankrig, 42055
        • CHU Saint-Etienne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study will involve 30 children aged between 2 to 18 years old who are not sedated, hospitalized in the pediatric intensive-care unit of the University Hospital of Saint-Etienne. They are expected to express an acute sensation of pain. This pain can be the result of a surgical procedure, a diagnostic or therapeutic procedure or a condition known as painful. All children studied benefit from analgesic treatment levels 2 or higher.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ANI Index for Hospitalized children

Each child will be registered upon arrival in the service and for a period of 24 hours. Registration will finish at the end of 24 hours or when the patient is discharged from the service. A FLACC scale (Face, Legs, Activity, Cry, Consolability scale) will be performed at the patient's input and then once every 4 hours corresponding to the patient's baseline. A FLACC scale will then be performed at each painful episode of the patient and 30 minutes after the end of production of analgesic treatment corresponding to the post-treatment painful condition of the patient.

A measurement of blood pressure will be performed at each pain rating by the patient assisted by the nurse.

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.
Andre navne:
  • ANI Index

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ANI Index
Tidsramme: 24 hours
ANI 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.
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HFnu Index
Tidsramme: 24 hours
High Standard Frequency Index (HFnu) of Short Term RR variability in heart rate (HRV) in the frequency domain will be measured at 24 hours.
24 hours
Ptot
Tidsramme: 24 hours
Ptot is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
VLF
Tidsramme: 24 hours
VLF (Very Low Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
LF
Tidsramme: 24 hours
LF (Low frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
HF
Tidsramme: 24 hours
HF (High Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
LF/HF Ratio
Tidsramme: 24 hours
LF (Low Frequencies) / HF (High Frequencies) Ratio is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
SDNN
Tidsramme: 24 hours
SDNN (Standard Deviation of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
SDANN
Tidsramme: 24 hours
SDANN (Standard Deviation of the Averages of NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
24 hours
pNN50
Tidsramme: 24 hours
pNN50 (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.
24 hours

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2016

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

10. maj 2016

Først indsendt, der opfyldte QC-kriterier

10. maj 2016

Først opslået (Skøn)

11. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1500012
  • 1956629 (Anden identifikator: CNIL)

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med ANI Index for Hospitalized children

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