Efficacy of newborn infant parasympathetic evaluation (NIPE) index versus standard hemodynamic response for guiding intraoperative fentanyl administration in children younger than 2 years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240214002

Enrollment

Registered

2024-02-14

Start date

2022-07-19

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children younger than 2 years scheduled for head, neck, or upper extremities surgery under general anesthesia NIPE, newborn infant parasympathetic evaluation, fentanyl, intraoperative, hemodynamic, guide, ANI, Analgesia nociception index, children, pediatrics

Interventions

Use NIPE guided intraoperative fentanyl administration when NIPE lower than 50 ,Use hemodynamic guided intraoperative fentanyl administration when 20% increase in HR and/or MBP

Active Comparator Device,Placebo Comparator Device

NIPE guided intraoperative fentanyl administration ,Standard hemodynamic response guided intraoperative fentanyl administration

Eligibility

Sex/Gender

All

Age

No minimum to 2 Years

Inclusion criteria

Inclusion criteria: Children younger than 2 years, ASA classification I-II, scheduled for elective head, neck, or upper extremities surgery undergoing skin incision under general anesthesia

Exclusion criteria

Exclusion criteria: Refusal of parents, Premature history, Cardiac arrythmia, implanted pacemaker or receiving drugs known to interfere with the autonomic nervous system, Surgical procedure under general anesthesia with additional regional anesthesia or intraoperative ketamine infusion, Planned ICU admission

Design outcomes

Primary

Measure	Time frame
Postoperative pain score postoperative Mean (SD), Median (min-max)	—

Secondary

Measure	Time frame
Postoperative fentanyl consumption postoperative Mean (SD), Median (min-max) ,Nausea/ vomiting postoperative Percentage,Sedation score postoperative Percentage,Respiratory depression postoperative Percentage	—

Countries

Thailand

Contacts

Public ContactPimprapa Muenpirom

Faculty of medicine, Khon Kaen university

pimprapa.m@kkumail.com0885632478

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026