Skip to main content
OpenTrials
Completed

NCT Number: NCT04195672

NIPE as an Indicator of Pain in Sedated/Ventilated Patient Under 3 Years-old Hospitalized in Intensive Care Unit

The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric intensive care unit.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The assessment of pain in patient hospitalized in intensive care remains a challenge, especially for patients which are unable to communicate their pain intensity. Self-reported scales are widely used for children's pain assessment but cannot be used in sedated or non-communicable patients. The gold standard for pain evaluation in sedated-ventilated patient in pediatric intensive care unit is the Comfort Behaviour Scale (CBS). However, this method remains subjective, depending on training and ability to use this clinical tool by the examiner. The Newborn Infant Parasympathetic Evaluation (NIPE) is a non-invasive system based on the analysis variability in high frequency (> 0.15 Hz) which reflects the parasympathetic activity related to respiratory fluctuations of heart rate. With a numerical index ranging from 0 to 100, NIPE values, measured continuously, has been developed to evaluate the degree of pain intensity. In this study, the hypothese is the NIPE could be used as an indicator of pain in sedated/intubated children under 3 years-old hospitalized in Pediatric intensive care unit.

This study did not change the procedure of care before or after and had no impact on care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All consecutive patient ≤ 3 year-old, mechanically ventilated

Exclusion criteria

  • Withdraw life-support,
  • unstable condition preventing planned routine procedures of care,
  • conditions precluding the use of NIPE (cardiac transplant, absence of sinus cardiac rhythm, apnea or respiratory rate ≤ 25 /min, pacemaker and use of atropine and/or isoprenaline and conditions of days of availability for NIPE)

Treatment and study plan

NIPE (MDoloris®) and CBS values

Device

During different procedures of care with the bed-side nurse, NIPE ware recorded. Monitoring started 15 minutes before care and continuously recorded until 10 minutes after the procedure. Pain assessment was evaluated by the CBS under 3 periods for each patient: 1- before any procedure (T1) representing the baseline, 2- during the procedure of care (T2), and 3- after the procedure (T3). Investigator who performed the CBS was blind to NIPE during the procedure recording.

This study did not change the procedure of care before or after and had no impact on care

Primary outcomes

  1. Newborn Infant Parasympathetic Evaluation

    Time frame: Through the study completion (18 months)

    Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old

  2. Comfort Behaviour Scale

    Time frame: Through the study completion (18 months)

    Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old

Secondary outcomes

  1. Newborn Infant Parasympathetic Evaluation

    Time frame: Through the study completion (18 months)

    Determination of pain detection threshold with Newborn Infant Parasympathetic Evaluation scale (0 to 100) using receiving operator characteristics (ROC) curve

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit

Acronym: NIPE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2019
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.