Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance

NCT02769598 | Completed

• 2 other identifiers: 15000121956629
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Measurement; Children; Child, Hospitalized

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• HFnu Index

  24 hours

• Ptot

  24 hours

• VLF

  24 hours

• LF

  24 hours

• HF

  24 hours

Study Arms (1)

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

Interventions

ANI Index for Hospitalized children 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.

Also known as: ANI Index

ANI Index for Hospitalized children

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugues PATURAL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)