Nociception Level Index as a Verbal Tool of Pain in Children

NCT05716243 | Active Not Recruiting

• 1 other identifier: 211-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postoperative pain; nociception level index; behavioral pain scores; general anesthesia; pain monitorization

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain assessment score : range 0-10; 0 = Relaxed and comfortable;1-3 = Mild discomfort; 4-6 = Moderate. pain. 7-10 = Severe discomfort/pain.

  postoperative 24 hour

Secondary Outcomes (1)

• The total amount of analgesic drug

  Intraoperative and postoperative 24 hour

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A will receive a standard intraoperative analgesia protocol

Device: The nociception level index measurement;postoperative

Group B

EXPERIMENTAL

Group B will receive a NOL-guided analgesia protocol

Device: The nociception level index monitorization

Interventions

The nociception level index monitorization DEVICE

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).

Group B

The nociception level index measurement;postoperative DEVICE

The nociception level index (NOL) will be used postoperatively

Group A

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anaesthesiologists (ASA) Physical Status classification I to II
• Patients whose parents will give informed consent for the study

You may not qualify if:

• Refusal to take part in the study
• History of allergies to drugs used in the study protocol
• History of premature birth
• Diagnosed metabolic syndrome
• Known hepatic insufficiency or decreased function
• Known renal insufficiency or decreased function
• Diagnosed with mental retardation

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• Gomez-Rios MA, Abad-Gurumeta A, Calvo-Vecino JM. Assessing nociception: steps towards intraoperative "full monitoring". Minerva Anestesiol. 2018 Oct;84(10):1123-1125. doi: 10.23736/S0375-9393.18.13191-9. No abstract available.

  PMID: 30274508 RESULT

• Ghiyasinasab M, Morisson L, Laferriere-Langlois P, Geraldo-Demers MA, Gelinas C, Nadeau-Vallee M, Verdonck O, Lahrichi N, Richebe P. Identification of the intraoperative antinociceptive effect of intravenous fentanyl using the Nociception Level (NOL) index versus clinical parameters in patients undergoing gynecological laparoscopic surgery: A secondary analysis of the NOLGYN study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101102. doi: 10.1016/j.accpm.2022.101102. Epub 2022 May 25.

  PMID: 35643392 RESULT

Related Links

• Assessment of Pain in Children Shobha Malviya MD University of Michiga

MeSH Terms

Conditions

Congenital Abnormalities; Pain, Postoperative

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthetist who is blind to study groups will make all postoperative assessments of pain by FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment score at the postoperative care unit, 6th 12th, and 24th hour postoperatively.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After standard monitorization, general anesthesia will be applied. Once the randomization is concluded to decide the group of the patient, Group A will receive 15 mg/kg (IV) paracetamol and 0,05 mg/kg morphine (IV). For once, NOL monitorization will be applied 30 minutes before waking up the patient to assess standard pain management and if the NOL value is higher than 25; 0,025 mg/kg morphine (IV) bolus doses (the maximum total intraoperative dose is concluded to be 0,5 mg/kg (IV)) will be added to ensure adequate analgesia for all patients within the study. On the contrary, patients within Group B will receive NOL monitorization from the beginning, all along the surgery.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: January 10, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 15, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)