NCT02769598|Completed
Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance
ANI-DOL
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ANI-DOL
Sponsor study identifier
Secondary identifiers
OTHER · CNIL
observational
30
1 country
1
Study Start
July 2016
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2016
Actual (reported)May 11, 2016
Actual (reported)July 2016
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)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
HFnu Index
24 hours
Ptot
24 hours
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Chu Saint-Etienne
Saint-Etienne, 42055, France
Hugues PATURAL, MD PhD
Centre Hospitalier Universitaire de Saint Etienne
30 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2016
First Posted
May 11, 2016
Study Start
July 2016
Actual (reported)Primary Completion
Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.
VLF
24 hours
LF
24 hours
HF
24 hours
Contact the study team to confirm eligibility.
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
January 27, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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