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

PHASE2RecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 29, 2025

Primary Completion Date

March 30, 2026

Study Completion Date

April 30, 2026

Conditions
Preoperative Sedation
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.

Trial Locations (1)

510632

RECRUITING

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

All Listed Sponsors
lead

Guangzhou Novaken Pharm Co., Ltd.

INDUSTRY

NCT07168720 - The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children | Biotech Hunter | Biotech Hunter