Clinical trial NCT05758090: Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years
Official title: Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Analgesia
Children, Only
Narcotic Use
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

Detailed description: During balanced anesthesia, hypnosis can be monitored with BIS, muscle relaxation can be monitored with a train-of-four, however, analgesia lacks precise monitoring. The anesthesiologist administers narcotics according to clinical signs and experience. Analgesia Nociception Index (ANI) has been introduced as an objective monitor for analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor has been introduced to assess analgesia in children under 2 years, however, clinical studies regarding its clinical efficacy are scarce.

The objective of this study is to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

Eligibility criteria: Inclusion Criteria:

* Newborn up to 2 years old
* ASA Status 1-2
* Undergoing elective surgery of upper part of body

Exclusion Criteria:

* Premature
* Arrhythmia
* Concomitant use of regional anesthesia
* Plan for ICU admission

Primary outcomes:
measure: Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
timeFrame: During 120 minutes in PACU
Secondary outcomes:
measure: Postoperative fentanyl consumption
timeFrame: During 120 minutes in PACU
measure: Postoperative sedation score
timeFrame: During 120 minutes in PACU
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Sirirat Tribuddharat, MD, PhD
role: STUDY_CHAIR
References:
citation: Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.
citation: Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.
citation: Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
citation: Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.