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

NCT ID: NCT07168720

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2026-04-30

Brief 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

Detailed 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.

Conditions

Preoperative Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Part 1

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.

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride Microneedles

Intervention Type: DRUG

Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.

part2

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.

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride Microneedles

Intervention Type: DRUG

In the high weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.

In the high weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.

placebo

Intervention Type: DRUG

In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

part3

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.

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride Microneedles

Intervention Type: DRUG

In the low weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.

In the low weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.

Placebo

Intervention Type: DRUG

In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

Interventions

Dexmedetomidine hydrochloride Microneedles

Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.

Intervention Type: DRUG

Dexmedetomidine hydrochloride Microneedles

In the high weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.

In the high weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.

Intervention Type: DRUG

placebo

In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

Intervention Type: DRUG

Dexmedetomidine hydrochloride Microneedles

In the low weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.

In the low weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.

Intervention Type: DRUG

Placebo

In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Novaken Pharm Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

HuaLiang Liu, Master

Role: CONTACT

liuhl@gznovaken.com

+86+13590957282

Facility Contacts

Hao Wang, Doctor

Role: primary

haowang@jnu.edu.cn

011-86-15521329479

Other Identifiers

BOJI2025016LH

Identifier Type: -

Identifier Source: org_study_id