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.

Study Overview

• Status: Completed
• Conditions: Children; Child, Hospitalized; Pain Measurement
• Intervention / Treatment: Device: ANI Index for Hospitalized children

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: ANI 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.; Other Names: ANI Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ANI Index	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HFnu Index	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	Ptot is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
VLF	VLF (Very Low Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
LF	LF (Low frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
HF	HF (High Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
LF/HF Ratio	LF (Low Frequencies) / HF (High Frequencies) Ratio is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
SDNN	SDNN (Standard Deviation of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.	24 hours
SDANN	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Nociception; Pediatric intensive care; Pain assessment scale; ANI index
• Other Study ID Numbers: 1500012; 1956629 (Other Identifier: CNIL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No