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

NCT07168720 | Recruiting Phase 2

• 1 other identifier: BOJI2025016LH
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Preoperative Sedation

Outcome Measures

Primary Outcomes (1)

• Adverse Event and Serious Adverse Event

  Incidence rate of Adverse Event and Serious Adverse Event

  Day2

Secondary Outcomes (3)

• Maximum blood concentration

  0 to 4 hour after administration

• Ramsay scale

  0 minute to 45 minutes after administration

• Sedation Success Rate

  0 minute to 45 minutes after administration

Study Arms (3)

Part 1

EXPERIMENTAL

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.

Drug: Dexmedetomidine hydrochloride Microneedles

part2

EXPERIMENTAL

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.

Drug: Dexmedetomidine hydrochloride Microneedles; Drug: placebo

part3

EXPERIMENTAL

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.

Drug: Dexmedetomidine hydrochloride Microneedles; Drug: Placebo

Interventions

Dexmedetomidine hydrochloride Microneedles DRUG

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

Part 1

Placebo DRUG

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

part2

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou Novaken Pharm Co., Ltd.: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510632, China

RECRUITING

Central Study Contacts

HuaLiang Liu, Master

CONTACT

+86+13590957282; liuhl@gznovaken.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 11, 2025
• Study Start: August 29, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data are available 6 months after the primary publication
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (1)