Nociception Level Index as a Verbal Tool of Pain in Children

NCT05716243 · tracked via the Priya Life Science Turkey tracker

Sponsor

Haseki Training and Research Hospital

Phase

Not applicable

Started

2023-01-10

Last updated

2025-03-19

Condition(s) studied

Pediatric PatientsOrthopedic SurgeryExtremity Fractures LowerExtremity Fractures UpperDeformity; Congenital

Investigational drug(s) / intervention(s)

The nociception level index monitorizationThe nociception level index measurement;postoperative

The nociception level index monitorization: The nociception level index (NOL) is one of the nociception monitors and stands out from the others with its multi-parameter evaluation. It is generated from five different parameters (heart rate, heart rate variability, skin conductance level, photo-plethysmography waveform amplitude, number of skin conductance fluctuations, and their time derivatives).

The nociception level index measurement;postoperative: The nociception level index (NOL) will be used postoperatively

Study summary

60 children under 6 years old, scheduled for orthopedic surgery for limb fracture or neuromuscular and bone deformities will be randomized by closed envelope method into two groups (n=30) either receiving standard pain management protocol or intraoperative NOL guided analgesia. Our study aims to evaluate the nociception monitor's effectiveness in providing adequate postoperative analgesia in pediatric patients. Besides, the difference between the amount of analgesic medication will be recorded.

Data to be recorded are total intraoperative morphine and postoperative rescue analgesic consumption, NOL values, and FLACC scores.

Eligibility

Sex

ALL

Min age

1 Year

Max age

6 Years

Healthy volunteers

Inclusion Criteria: * American Society of Anaesthesiologists (ASA) Physical Status classification I to II * Patients whose parents will give informed consent for the study Exclusion Criteria: * Refusal to take part in the study * History of allergies to drugs used in the study protocol * History of premature birth * Diagnosed metabolic syndrome * Known hepatic insufficiency or decreased function * Known renal insufficiency or decreased function * Diagnosed with mental retardation

Primary outcome measure(s)

Pain Scores — postoperative 24 hour
Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain assessment score : range 0-10; 0 = Relaxed and comfortable;1-3 = Mild discomfort; 4-6 = Moderate. pain. 7-10 = Severe discomfort/pain.

Trial sites (1)

Facility	City	Region	Status
Haseki Training and Research Hospital	Istanbul	Sultangazi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05716243 on ClinicalTrials.gov ↗ ← All trials in Turkey