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Can a safer opioid choice stop Kids' Post-Surgery agitation?

NCT ID NCT07800845

Symptom relief Sponsor: Konya City Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial compares two short-acting opioids, remifentanil and fentanyl, given during general anesthesia to see which better prevents emergence delirium, a state of confusion and agitation that affects up to 80% of children after surgery. Researchers will enroll 176 children aged 7 to 12 undergoing urologic surgery, randomly assigning half to each drug. The main goal is to measure how many children in each group develop delirium using a standard scale, with secondary checks on recovery speed and heart stability. The results could guide anesthesiologists in choosing the right opioid to make waking up from anesthesia smoother and safer for children.

What this could mean

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

Active substance
remifentanil (an opioid) compared with fentanyl (another opioid), given during general anesthesia
What this could lead to
If remifentanil works better than fentanyl, it could give anesthesiologists a clear choice to reduce distressing post-anesthesia agitation in children, leading to safer recovery and shorter hospital stays.
What could go wrong
This is a single-center trial with 176 children, and earlier studies on remifentanil have shown mixed results, with some suggesting it might increase agitation. The outcome depends on careful measurement and may not apply to all pediatric surgeries.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Ages

7 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: Age 7 to 12 years American Society of Anesthesiologists (ASA) physical status 1 or 2 Scheduled for elective pediatric urologic surgery Surgery planned under general anesthesia with a laryngeal mask airway Written informed consent from a parent or legal guardian, with assent from the child Exclusion Criteria: History of an abnormal airway Reactive airway disease Respiratory tract infection within the preceding 3 weeks Abnormal cognitive development or developmental delay Known allergic reaction to any medication used in the protocol Chronic use of opioids, sedatives, or psychoactive medication

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium Postoperative Complications

As listed by the trial registrant

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

Anesthesia recovery period Emergence agitation Emergence delirium Postoperative complications Urologic surgical procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yasin Tire

    Konya, Meram, 42140, Turkey (Türkiye)

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