The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children

Exclusion Criteria13

• 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.