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Nociception Level Index as a Verbal Tool of Pain in Children

NCT05716243 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-19

No results posted yet for this 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.

Conditions

  • Pediatric Patients
  • Orthopedic Surgery
  • Extremity Fractures Lower
  • Extremity Fractures Upper
  • Deformity; Congenital

Interventions

DEVICE

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).

DEVICE

The nociception level index measurement;postoperative

The nociception level index (NOL) will be used postoperatively

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Principal Investigators

  • Berna Caliskan, MD · Haseki Training and Research Hospital Anesthesiology and Reanimation Department

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-05-30
Completion
2025-06-15

Countries

  • Turkey (Türkiye)

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 NCT05716243 on ClinicalTrials.gov