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Which pain monitor works best for kids under anesthesia?

NCT ID NCT05998564

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two non-invasive monitors that track pain in children aged 1-12 during surgery. The monitors measure skin conductance and a pain index to see how well they detect pain events. Researchers compared their readings to find which one is more reliable for guiding pain treatment.

What this could mean

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

What this could lead to
If successful, this could help doctors choose the best pain monitor for children under anesthesia, improving pain management.
What could go wrong
This is a small, completed observational study with only 50 children. Results may not apply to all surgeries or ages, and neither monitor is proven to improve outcomes.

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

50 people

The number who actually took part.

Started

Sep 2023

Finished

Oct 2024

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

A total of 50 patients. 25 patients aged 1-4 years old, and 25 patients aged 5-12 years old that are scheduled to undergo elective surgery under general anaesthesia. Patients will be enrolled after obtaining written informed consent. We decided to evaluate the SCA and NOL index in two age groups because of the significant differences of maturations of the bodies across different ages that might influence the measurements made by the SCA and NOL monitor. Furthermore the maturation of the brain of a paediatric patient also differs significantly across different ages. Leading to significant differences in EEG patterns and corresponding BIS monitor values across age groups 1-4 and groups 5-11. Therefore, assessing the NOL and SCA in these two difference age groups results in a better ability to assess the homogeneity of the population as we will also be able to quantify and compare the depth of anesthesia through BIS monitor in these two age groups.

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 * Written informed consent obtained from subject or/and subject's legal representatives. Exclusion Criteria: * Known allergy to the adhesive tape used in the sensors. * Patients that do not meet the inclusion criteria will be excluded. * No free available limb to attach the probes to.

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Conditions

The condition(s) this trial relates to.

Nociceptive Pain Pain

As listed by the trial registrant

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

Anesthesia Nociceptive pain Pain

Contacts and locations

Locations

  • Radboudumc

    Nijmegen, Gelderland, Netherlands

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