NCT05758090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

February 23, 2023

Last Update Submit

April 21, 2024

Conditions

Post Operative PainAnalgesiaChildren, OnlyNarcotic Use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative fentanyl consumption

    During 120 minutes in PACU

  • Postoperative sedation score

    During 120 minutes in PACU

Study Arms (2)

Group NIPE

EXPERIMENTAL

Intraoperative fentanyl administration will be guided by NIPE protocol

Procedure: NIPE monitor

Group Control

PLACEBO COMPARATOR

Intraoperative fentanyl administration will be guided by clinical signs

Procedure: Control

Interventions

NIPE monitorPROCEDURE

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.

Group NIPE
ControlPROCEDURE

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

Group Control

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn up to 2 years old
  • ASA Status 1-2
  • Undergoing elective surgery of upper part of body

You may not qualify if:

  • Premature
  • Arrhythmia
  • Concomitant use of regional anesthesia
  • Plan for ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (4)

  • Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.

    PMID: 30793426RESULT

  • Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.

    PMID: 33590418RESULT

  • Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.

    PMID: 33329766RESULT

  • Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.

    PMID: 31185928RESULT

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Sirirat Tribuddharat, MD, PhD

    Khon Kaen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 7, 2023

Study Start

March 10, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)