No-Needle sedation patch for kids enters human trials

NCT ID NCT07168720

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a microneedle patch containing dexmedetomidine to sedate children aged 2–6 before surgery. The patch aims to replace needles or oral medicine, making the experience less scary. Researchers will check how well it works, its safety, and how the drug moves through the body in 64 children.

What this could mean

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

Active substance
dexmedetomidine hydrochloride microneedle patch
What this could lead to
If it works, this could offer a needle-free, less stressful way to sedate young children before surgery.
What could go wrong
This is a small, early-phase trial (64 kids) testing different doses. It may not prove effective or safe enough for routine use.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

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

Started

Aug 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 6 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: * Aged 2 years to 6 years (inclusive ), any genders; * Body weight meeting the criteria: * Scheduled to undergo general anesthesia for surgery/procedure * American Society of Anesthesiologists(ASA) I\~II * Provide written informed consent from the legal guardian Exclusion Criteria: * Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients; * Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives; * History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases; * History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product; * History of thoracic, cardiac, or brain surgery; * Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs; * Abnormal liver/kidney function test values (ALT or AST \>1.5 times the upper limit of normal \[ULN\], or bilirubin \>1.5 × ULN, or serum creatinine \>1.5 × ULN); * Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure); * Anemia requiring treatment, as judged by the investigator (hemoglobin \<80 g/L); * Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives; * Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening; * Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate; * Other situations deemed by the investigator as unsuitable for inclusion.

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As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

    RECRUITING

    Guangzhou, Guangdong, 510632, China

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