Clinical trial NCT02834481: Assessment of Pain Monitoring With ANI/NIPE Monitor Program in Pediatric Cardiac Surgery Postoperative.
Official title: ANI/NIPE Assessment of Pain Monitoring With ANI (Analgesia Nociceptive Index)/NIPE (Newborn Infant Parasympathetic Evaluation) Monitor Program in Pediatric Cardiac Surgery Postoperative.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Pain Care
Pediatric and Neonatal Intensive Care Units
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 20
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective is to assess correlation between ANI/NIPE values and external evaluation COMFORT B scale during painful medical cares and during said comfort medical cares in intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery with extracorporeal circulation.

Detailed description: ANI/NIPE monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. It uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia).

Developed in surgical units, the ANI monitor has rarely been studied in pediatrics (only 2 publications, and only concerning peroperative measures). The NIPE monitor has only been available since 2014. Nevertheless, adult surveys and fundamental scientific publications on heart rate variations suggest that these monitors can evaluate pain on a continuous way. No study has been led in pediatric intensive care units.

In our study, a continuous blinded monitoring will be set up as soon as patients' admittance for all eligible subjects. We will study, for children in cardiac post-surgery, ANI/ NIPE values and COMFORT B values during both painful and non-painful cares to determine correlation between those values. We will analyze a posteriori the ANI/NIPE values, through a standardized protocol, to recount the sequence of care and to determine discrepancies in drug consumption. Data gathering will be made in the first 48h after admittance in Pediatric Intensive Care Units (PICU). Patients will not be followed after leaving PICU.

Eligibility criteria: Inclusion Criteria:

* ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation, consent of the parental control, children benefiting from social security system

Exclusion Criteria:

* Heart rhythm disorder, use of heart rhythm disorder treatments, use of active pacemaker, which make ANI/NIPE values impossible to interpret

Primary outcomes:
measure: Comparison between ANI/NIPE values and COMFORT B scale values assessed by coefficient of correlation in patients upper than two years old and in patients under two years old
timeFrame: Through the study completion (24 months)
Secondary outcomes:
measure: Determination of pain detection threshold with ANI/NIPE scale using receiving operator characteristics receiving operator characteristics (ROC) curve.
timeFrame: Through the study completion (24 months)
measure: Determination of pain detection threshold with COMFORT B scale using ROC curve.
timeFrame: Through the study completion (24 months)
measure: Evolution of ANI/NIPE value during pain care
timeFrame: Through the study completion (24 months)
measure: Evolution of ANI/NIPE value during comfort care
timeFrame: Through the study completion (24 months)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: PELLUAU Sonia, MD
role: PRINCIPAL_INVESTIGATOR
References: