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Search / Trial NCT07084935

Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jul 24, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Nociception Monitoring Pediatric Population Nol Index Surgical Pleth Index

ClinConnect Summary

This clinical trial is studying two different ways to monitor pain signals in children who are having surgery under general anesthesia. Both methods, called the Nociception Level (NOL) index and the Surgical Pleth Index (SPI), use signals from the body’s nervous system to detect how the child’s body responds to pain during surgery. The study aims to see which method is better at measuring these pain responses in children between the ages of 1 and 12 years old.

Children who are generally healthy or have mild to moderate health issues and are scheduled for planned surgery with general anesthesia may be eligible to take part. Kids with ongoing pain problems, those already using pain medications regularly, or those who can’t have sensors attached to a limb won’t be included. If a child participates, the monitors will be placed on them during surgery to measure their body’s response to pain, without changing their usual care. This study will help doctors understand which monitoring tool works best to keep children safe and comfortable during surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female
  • ASA I, ASA II and ASA III
  • Aged 1 to 12 years old
  • Scheduled to undergo elective surgery with general anaesthesia
  • Exclusion Criteria:
  • Patients with chronic pain
  • Patients with chronic analgesia usage.
  • Known allergy to the adhesives used in the sensors.
  • No free available limb to attach the probes to.

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Nijmegen, Gelderland, Netherlands

Patients applied

0 patients applied

Trial Officials

Ignacio Malagon, Professor

Principal Investigator

Radboud University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported