Children Clinical Trial
Official title:
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.
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.
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