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The Newborn Infant Parasympathetic Evaluation (NIPE TM) index is superior to heart rate in detecting intraoperative acute pain in healthy as well as critically ill children below 2 years - an observatories study

The Newborn Infant Parasympathetic Evaluation (NIPE TM) index is superior to heart rate in detecting intraoperative acute pain in healthy as well as critically ill children below 2 years - an observatories study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025183
Enrollment
51
Registered
2021-07-13
Start date
2019-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric surgery in general anesthesia

Interventions

Group 1: Observatorium study: NIPE monitoring was installed with the arrival of the patients in the operation room and was continuously performed until to transfer either the peripheral ward or the NI

Sponsors

Universitätsklinikum Bonn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: Children below 2 years of age, undergoing pediatric surgery involving general anaesthesia

Exclusion criteria

Exclusion criteria: Children older than 2 years of age, Children whose parents were unable or unwilling to provide written consent

Design outcomes

Primary

MeasureTime frame
Intraoperative measurement of NIPE index and heart rate was continuously performed using the NIPE monitor. Two different scales (KUS, Kindliche Unbehagens-und Schmerzskala and PAED, Pediatric Anesthesia Emergence Delirium) as well as a pain questionnaire were used to assess postoperative pain levels and emergence delirium. The aim of our study was to assess the feasibility of the NIPE index to correctly indicate intraoperative pain perception in comparison to changes in heart rate to guide analgesia.

Secondary

MeasureTime frame
With this trial we wanted to show that the NIPE provides a more reliable and exact Evaluation of intraoperative nociception than the heart rate in healthy (group 1) as well as critically ill pediatric patients (group 2). Moreover we wanted to investigate wether there are differences in the reaction to painful stimuli between both groups.

Countries

Germany

Contacts

Public ContactClaudia Neumann

Universitätsklinikum bonn

claudia.neumann@ukbonn.de0228 287 14114

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026