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

Khon Kaen University

Status: Completed

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

Treatments: Procedure: Control; Procedure: NIPE monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05758090

HE651243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Group NIPE

Experimental group

Description:

Intraoperative fentanyl administration will be guided by NIPE protocol

Treatment:

Procedure: NIPE monitor

Group Control

Placebo Comparator group

Description:

Intraoperative fentanyl administration will be guided by clinical signs

Treatment:

Procedure: Control