Dexmedetomidine microneedle patch for preoperative sedation in young children

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

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

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 2 Years to 6 Years
• Sex: All
• Sponsor: Guangzhou Novaken Pharm Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07168720 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: HuaLiang Liu, Master

Conditions Preoperative Sedation