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NCT05716243
Nociception Level Index as a Verbal Tool of Pain in Children
Conditions: Pediatric Patients, Orthopedic Surgery, Extremity Fractures Lower, Extremity Fractures Upper, Deformity; Congenital
Sex: All
Ages: 1 Year – 6 Years
Phase: NA
Enrollment: 60
Sponsor: Haseki Training and Research Hospital
Location: Turkey
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 Criteria
Inclusion Criteria:American Society of Anaesthesiologists (ASA) Physical Status classification I to IIPatients whose parents will give informed consent for the studyExclusion Criteria:Refusal to take part in the studyHistory of allergies to drugs used in the study protocolHistory of premature birthDiagnosed metabolic syndromeKnown hepatic insufficiency or decreased functionKnown renal insufficiency or decreased functionDiagnosed with mental retardation
Source: ClinicalTrials.gov (NCT05716243). StuddyBuddy aggregates publicly available trial information.