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No opioids, less confusion? study tests anesthesia change for children

NCT ID NCT07191652

Knowledge-focused Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 128 children aged 2-18 who had ear, nose, or throat surgery. Researchers compared standard opioid-based anesthesia to opioid-free anesthesia to see if it reduced post-surgery agitation and delirium. The goal was to find a way to help children recover more calmly and with less pain.

What this could mean

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

Active substance
opioid-free anesthesia
What this could lead to
If it works, this could point toward a safer anesthesia method for children that reduces post-surgery confusion and pain.
What could go wrong
This is a small, completed retrospective study, not a large trial. Results may not apply to all children or surgeries, and the findings are not yet confirmed.

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

128 people

The number who actually took part.

Started

Mar 2026

Finished

May 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

The study population will consist of 126 pediatric patients aged between 2 and 18 years, who are classified as ASA physical status I or II and are scheduled to undergo elective ear, nose, and throat (ENT) surgery under general anesthesia. These patients will be included based on the eligibility criteria and will be evaluated retrospectively. Patients will be excluded from the study if they fall under ASA classifications III, IV, V, or VI, or if they have a diagnosis of liver failure, advanced heart block (second or third degree), acute cerebrovascular events, mental retardation, or have a tracheostomy. Additionally, any patient or guardian who declines participation will also be excluded.

Ages

2 to 18 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:The study will include 126 patients * Aged 2-18 years * ASA I-II * Undergoing elective tonsillectomy, adeoidectomy, cochlear implant surgery under general anesthesia. Exclusion Criteria: * Patients with ASA 3,4, 5, or 6 * Liver failure * Advanced heart block (second and third degree) * Acute cerebrovascular events * Mental retardation * Patients with tracheostomy * Those unwilling to participate

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium Pain, Postoperative

As listed by the trial registrant

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

Delirium, postoperative Ear throat nose surgery Pain, postoperative

Contacts and locations

Locations

  • Cerrahpasa Faculty of Medicine

    Istanbul, Istanbul, Turkey (Türkiye)

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