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

Not Applicable

Completed

• Conditions: Post Operative Pain; Analgesia; Children, Only; Narcotic Use
• Interventions: Procedure: NIPE monitor; Procedure: Control

• Registration Number: NCT05758090
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-04
• Study First Posted: 2023-03-07
• Study Start: 2023-03-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group NIPE	NIPE monitor	Intraoperative fentanyl administration will be guided by NIPE protocol
Group Control	Control	Intraoperative fentanyl administration will be guided by clinical signs

Primary Outcome Measures

Name	Time	Method
Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)	During 120 minutes in PACU	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative fentanyl consumption	During 120 minutes in PACU	Fentanyl administration in PACU
Postoperative sedation score	During 120 minutes in PACU	Sedation score (0-3; higher scores mean a worse outcome) in PACU

Trial Locations

Locations (1)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand