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
- Conditions
- Pediatric surgery in general anesthesia
- Registration Number
- DRKS00025183
- Lead Sponsor
- niversitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Children below 2 years of age, undergoing pediatric surgery involving general anaesthesia
Exclusion Criteria
Children older than 2 years of age, Children whose parents were unable or unwilling to provide written consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.