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RECRUITING
NCT07168720
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexmedetomidine hydrochloride Microneedles

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

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.

DRUG

placebo

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

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.

DRUG

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