Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance

NCT ID: NCT02769598

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Pain Measurement; Children; Child, Hospitalized

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ANI Index for Hospitalized children

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ANI Index

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugues PATURAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

1956629

Identifier Type: OTHER

Identifier Source: secondary_id

1500012

Identifier Type: -

Identifier Source: org_study_id