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

Sponsor

Khon Kaen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758090

Collaborator

(none)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Analgesia Children, Only Narcotic Use	Procedure: NIPE monitor Procedure: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group NIPE Intraoperative fentanyl administration will be guided by NIPE protocol	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.
Placebo Comparator: Group Control Intraoperative fentanyl administration will be guided by clinical signs	Procedure: Control Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.

Arm

Intervention/Treatment

Experimental: Group NIPE

Intraoperative fentanyl administration will be guided by NIPE protocol

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.

Placebo Comparator: Group Control

Intraoperative fentanyl administration will be guided by clinical signs

Procedure: Control

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 2 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Khon Kaen University

Investigators

Study Chair: Sirirat Tribuddharat, MD, PhD, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thepakorn Sathitkarnmanee, Associate Professor, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT05758090

Other Study ID Numbers:

HE651243

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Mar 7, 2023