The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride… (NCT07168720) | Clinical Trial Compass
RecruitingPhase 2
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
China64 participantsStarted 2025-08-29
Plain-language summary
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
Who can participate
Age range2 Years – 6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 arrh…