Actively Recruiting
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Led by Guangzhou Novaken Pharm Co., Ltd. · Updated on 2025-09-19
64
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2 years to 6 years (inclusive), any gender
- Body weight meeting the criteria
- Scheduled to undergo general anesthesia for surgery or procedure
- American Society of Anesthesiologists (ASA) physical status I or II
- Provide written informed consent from the legal guardian
You will not qualify if you...
- Allergy to any component of Dexmedetomidine Hydrochloride Microneedle Patch or related products
- Received sedative or analgesic drugs within 7 half-lives prior to randomization
- History of bronchial asthma, chronic or severe respiratory diseases
- History of neurological diseases affecting evaluation
- History of thoracic, cardiac, or brain surgery
- Skin conditions unsuitable for patch application on forearms or thighs
- Abnormal liver or kidney function beyond specified limits
- Severe cardiovascular diseases
- Anemia requiring treatment (hemoglobin <80 g/L)
- Use of highly selective alpha-2 agonists or antagonists within 7 half-lives prior to randomization
- Participation in another clinical trial within 3 months prior to screening
- Severe psychiatric illness preventing cooperation
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, China, 510632
Actively Recruiting
Research Team
H
HuaLiang Liu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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