Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 2 to 6

Dexmedetomidine microneedle patch for preoperative sedation in young children

Official title: Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children

Run by Guangzhou Novaken Pharm Co., Ltd. · NCT07168720 · Data updated 2026-11-12

This trial will test whether a small microneedle patch that delivers dexmedetomidine can safely sedate children aged 2–6 before anesthesia.

More Preoperative Sedation trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages2 Years to 6 Years
SexAll
Enrollment64 (estimated)
SponsorGuangzhou Novaken Pharm Co., Ltd.
Industry-sponsored
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedAugust 29, 2025
Main results expectedMarch 30, 2026
Study endsApril 30, 2026
Registry record updatedSeptember 19, 2025
Trial IDNCT07168720 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 2 to 6 years who are scheduled for general anesthesia, meet protocol weight and ASA I–II criteria, and whose legal guardian can provide written informed consent are ideal candidates.

Probably not a fit

Children with known allergy to dexmedetomidine or patch components, recent use of other sedatives, significant respiratory or neurological disease, or ASA class III or higher are unlikely to benefit or be eligible for this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIa trial of dexmedetomidine hydrochloride delivered via microneedle patches for preoperative sedation in children. Eligible children aged 2 to 6 years scheduled for general anesthesia with ASA class I–II will be randomized to receive either the active microneedle patch or a matching placebo patch. The study will collect safety data, measures of sedation effectiveness, and population pharmacokinetic profiles while caregivers follow physician instructions and provide informed consent. Outcomes in the active and placebo arms will be compared to determine whether the microneedle patch provides effective and well-tolerated preoperative sedation.

Why it matters

Potential benefit: If successful, the microneedle patch could offer a less invasive, easier-to-administer option to sedate young children before surgery while reducing needle-based dosing and improving comfort.

How similar studies have gone: Other routes of dexmedetomidine (e.g., intranasal, intravenous) have been used successfully for pediatric sedation, but microneedle delivery for this indication is relatively novel with limited clinical data.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.