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Can a nasal spray replace a syrup for Kids' procedure sedation?

NCT ID NCT07768566

Symptom relief Sponsor: Seoul National University Childrens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether a sedative given as a nasal spray (dexmedetomidine) works as well as a standard oral syrup (chloral hydrate) for calming children during painful orthopedic procedures. About 44 children aged 7 to 12 will be randomly assigned to one of the two treatments, with both children and doctors unaware of which they receive. The study measures how well sedation works, how quickly children fall asleep and wake up, and any side effects. The goal is to find a safer, easier, and more comfortable way to sedate children for these procedures.

What this could mean

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

Active substance
intranasal dexmedetomidine
What this could lead to
If effective, intranasal dexmedetomidine could offer a needle-free, easier-to-tolerate sedation option for children undergoing painful procedures.
What could go wrong
This is a small, early-stage trial, and results may not apply broadly. Both sedatives carry risks like breathing problems or allergic reactions.

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 44 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

Dec 2028

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: * Children 7 through 12 years of age who require a painful orthopedic procedure in the pediatric orthopedic outpatient clinic or emergency department * American Society of Anesthesiologists physical status class I or II * The participant and parent or legal guardian understand the purpose of the study, the parent or legal guardian provides written informed consent, and the child provides assent Exclusion Criteria: * History of allergy to dexmedetomidine or chloral hydrate * History of cardiovascular disease, including bradycardia or hypotension, or severe respiratory disease * Current sedative use or receipt of another sedative within the previous 24 hours * Inability to receive intranasal administration, including nasal obstruction or severe rhinitis * Investigator determination that participation is inappropriate

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As listed by the trial registrant

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

Pediatric procedural sedation

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

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Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea