Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Post Operative Pain, Analgesia, Children, Only, Narcotic Use

Intervention / Treatment
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* Procedure: NIPE monitor
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group NIPE<br>Intraoperative fentanyl administration will be guided by NIPE protocol | Procedure: NIPE monitor<br>* Procedure/Surgery: NIPE protocol. Give intraoperative fentanyl according to NIPE value. NIPE score 50-70 indicates optimal narcotic effect. NIPE score > 70 indicated overdosage of narcotic and narcotic should be withheld. NIPE score < 50 indicates inadequate narcotic and narcotic should be given.<br>|
| Placebo Comparator: Group Control<br>Intraoperative fentanyl administration will be guided by clinical signs | Procedure: Control<br>* Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale) | Assess pain using a FLACC score every 15 minutes. FLACC has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain. | During 120 minutes in PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative fentanyl consumption | Fentanyl administration in PACU | During 120 minutes in PACU | 
| Postoperative sedation score | Sedation score (0-3; higher scores mean a worse outcome) in PACU | During 120 minutes in PACU |