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

Guangzhou Novaken Pharm Co., Ltd.

Status and phase: Enrolling; Phase 2

Conditions: Preoperative Sedation

Treatments: Drug: Dexmedetomidine hydrochloride Microneedles; Drug: placebo; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168720

BOJI2025016LH

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children

Full description

A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.

Enrollment: 64 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 3 patient groups

Part 1

Experimental group

Description:

16 Participants will receive the Dexmedetomidine hydrochloride Microneedles identified in Part 1 of the study. Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group. A total of 16 children with a high body weight (weight ≥ 19.4 kg) will be included. They will be randomly divided into a medium-pressure group and a low-pressure at a ratio of 1:1.

Treatment:

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: Dexmedetomidine hydrochloride Microneedles

part2

Experimental group

Description:

Participants will receive the dose identified in Part 1 of the study. A total of 24 children with high body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.

Treatment:

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: placebo

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: Dexmedetomidine hydrochloride Microneedles

part3

Experimental group

Description:

Participants will receive the dose identified in Part 2 of the study. A total of 24 children with low body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.

Treatment:

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: Placebo

Drug: Dexmedetomidine hydrochloride Microneedles

Drug: Dexmedetomidine hydrochloride Microneedles