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Which monitor reads a Child's pain best during surgery?

NCT ID NCT07084935

Knowledge-focused Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study compares two devices that track pain signals in children under general anesthesia: the NOL index and the SPI. Both monitors read the body's automatic responses to pain, but they use different methods. Researchers will test how each monitor reacts to a standard pain pulse and to the actual start of surgery in 40 children aged 1 to 12. The goal is to see which device gives a clearer signal, which could help anesthesiologists manage pain more precisely in young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Comparison of two monitoring devices: the Nociception Level (NOL) index and the Surgical Pleth Index (SPI), used during general anesthesia in children.
What this could lead to
If one monitor proves better at detecting pain in children under anesthesia, it could improve how doctors manage pain during surgery for young patients.
What could go wrong
This is a small observational study, so results may not apply to all children or surgeries. The monitors may not clearly differ in their ability to detect pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Jul 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

pediatric patients scheduled to undergo surgery with general anesthesia at the Radboud university medical centre in Nijmegen, the Netherlands

Ages

1 year to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Nociceptive Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Nociception monitoring Nociceptive pain Pediatric anesthesia

Contacts and locations

Locations

  • Radboud university medical centre

    Nijmegen, Gelderland, 6525 GA, Netherlands

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