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Nociception Level Index as a Verbal Tool of Pain in Children

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Jun 30, 2023 to May 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 30, 2023 to Jun 15, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05716243
Lead Sponsor Haseki Training and Research Hospital
Conditions
(from sponsor)		 Pediatric Patients, Orthopedic Surgery, Extremity Fractures Lower, Extremity Fractures Upper, Deformity; Congenital
Related terms Congenital Abnormalities, Postoperative Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov