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Which sedative works best for kids after cleft surgery? new study aims to find out

NCT ID NCT07340008

Symptom relief Sponsor: University Medical Centre Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares three different sedatives (ketamine, nalbuphine, and dexmedetomidine) given to 60 children aged 6 months to 3 years who need stitches removed after cleft lip or palate surgery. The goal is to see which drug works fastest and safest to keep the child calm and comfortable during the procedure. Results will help doctors choose the best option for this common, minor surgery.

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 60 people

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

Started

Sep 2025

Expected to finish

Jan 2029

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

6 months to 3 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 6 months to 3 years * Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip * American Society of Anesthesiologists (ASA) physical status I or II * Written informed consent obtained from parents or legal guardians * Slovene-speaking family to ensure understanding and compliance * No contraindications to the use of study medications Exclusion criteria: * Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine * ASA physical status greater than II * Significant neurological, psychiatric, or respiratory disorder * Active or recent upper respiratory tract infection * Refusal of parental or guardian consent * Developmental disorder affecting communication or cooperation

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip and alveolus cleft lip/palate cleft palate orofacial cleft

As listed by the trial registrant

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

Alveolar ridge defect Cleft lip and palate Orofacial clefts

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

  • Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

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