Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance
Condition: Pain Measurement; Children; Child, Hospitalized
Study type: Observational

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.
    

Intervention name(s): ANI Index for Hospitalized children
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): ANI Index
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Pain; Nociception; Pediatric intensive care; Pain assessment scale; ANI index