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New nasal spray could ease Kids' surgery fears

NCT ID NCT06853431

Symptom relief Sponsor: Second Affiliated Hospital of Wenzhou Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a nasal spray combining two medicines (dexmedetomidine and esketamine) to help children aged 1-6 relax before surgery. The goal is to find the best dose that makes kids calm enough for a smooth start to anesthesia. About 80 children will take part to see how well and how quickly the spray works.

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 80 people

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

Started

Mar 2025

Expected to finish

Nov 2025

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

12 to 72 months

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: 1. ASA physical status classification Grade I or II; 2. Age 1-6 years old; 3. Children who need to undergo general anesthesia for elective surgery; 4. Weight within the normal range; 5. Signed informed consent form. - Exclusion Criteria: 1. The child's guardian or the child themselves refuses to participate in the study; 2. Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia; 3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications; 4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases; 5. Individuals with an upper respiratory tract infection within the past two weeks; 6. Individuals with other diseases that may cause harm to the subject. -

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As listed by the trial registrant

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

Children Dexmedetomidine ED50 ED95 Esketamine Preoperative anxiety Preoperative sedation Preoperative sedation of children

How to take part

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

  1. The places running it

    2 sites. 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

  • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

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