No-Needle sedation patch for kids enters human trials
NCT ID NCT07168720
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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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
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2 to 6 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
RECRUITINGGuangzhou, Guangdong, 510632, China
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