Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could skipping opioids make Kids' cleft surgery safer?

NCT ID NCT07557576

Symptom relief Sponsor: Iva Smiljanić Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether an opioid-free anesthesia approach using ketamine and dexmedetomidine can control pain and reduce agitation just as well as standard opioid anesthesia in 90 children aged 3 months to 7 years undergoing cleft lip or palate repair. Researchers will measure pain, agitation, and stress markers after surgery. The goal is to find a safer way to manage pain with fewer side effects like nausea and breathing trouble.

What this could mean

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

Active substance
Ketamine, Dexmedetomidine, Fentanyl, Propofol, Sevoflurane
What this could lead to
If successful, this could show that opioid-free anesthesia is safer and just as effective for children undergoing cleft surgery, reducing side effects like nausea and breathing problems.
What could go wrong
This is a small, early-stage trial (90 children) comparing two approaches, so results may not apply to all children or surgeries. The opioid-free method might not control pain as well as expected.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Started

May 2024

Expected to finish

Sep 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

3 months to 7 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: * ASA physical status I-II * Body weight \>5 kg * Age ≥3 months for cleft lip repair and ≥9 months for cleft palate repair * Hemoglobin \>100 g/L Exclusion Criteria: * ASA physical status III-IV * Body weight \<5 kg * Age \<3 months for cleft lip repair or \<9 months for cleft palate repair * Hemoglobin \<100 g/L * Acute illness * Respiratory infection or vaccination within 2 weeks prior to surgery * Requirement for perioperative intensive care

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Agitation, emergence are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

agnosia cleft lip cleft lip/palate cleft palate Emergence Delirium orofacial cleft pain agnosia

As listed by the trial registrant

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

Agitation, emergence Analgesia Analgesia assessment Cleft lip palate Orofacial cleft Pediatric

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

  • University Hospital Dubrava

    RECRUITING

    Zagreb, 10000, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.