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The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Sponsor: Guangzhou Novaken Pharm Co., Ltd.
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
Official title: Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children
Key Details
Gender
All
Age Range
2 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-08-29
Completion Date
2026-04-30
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine hydrochloride Microneedles
Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
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.
placebo
In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
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.
Placebo
In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
Locations (1)
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, China