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NCT Number: NCT05758090

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

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.

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Key information

Conditions

Post Operative Pain Agnosia Analgesia Children, Only Narcotic Use Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIPE monitor

Procedure

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.

Control

Procedure

Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.

Primary outcomes

  1. Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)

    Time frame: 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 outcomes

  1. Postoperative fentanyl consumption

    Time frame: During 120 minutes in PACU

    Fentanyl administration in PACU

  2. Postoperative sedation score

    Time frame: During 120 minutes in PACU

    Sedation score (0-3; higher scores mean a worse outcome) in PACU

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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