Clinical Trial

Nociception Level Index as a Verbal Tool of Pain in Children

Active, Not Recruiting
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Record status
This record was last updated March 19, 2025 (before its estimated May 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-02-04.
Status change: Recruiting → Active, Not Recruiting 2025-03-17
Trial Details
NCT Number NCT05716243
Lead Sponsor Haseki Training and Research Hospital
Conditions Pediatric Patients, Orthopedic Surgery, Extremity Fractures Lower, Extremity Fractures Upper, Deformity; Congenital
Enrollment 60 participants
Start Date 2023-01-10
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-03-19