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

NCT05758090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-04-23

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

NIPE monitor

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.

PROCEDURE

Control

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

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Sirirat Tribuddharat, MD, PhD · Khon Kaen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758090 on ClinicalTrials.gov