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ACTIVE NOT RECRUITING
NCT05716243
NA

Nociception Level Index as a Verbal Tool of Pain in Children

Sponsor: Haseki Training and Research Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Nociception Level Index on Postoperative Pain Management in Pediatric Patients

Key Details

Gender

All

Age Range

1 Year - 6 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-01-10

Completion Date

2025-06-15

Last Updated

2025-03-19

Healthy Volunteers

No

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

Locations (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)