NCT07168720

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

Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Guangzhou Novaken Pharm Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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

Detailed description

A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.

Conditions

• Preoperative Sedation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-29
• Primary completion: 2026-03-30
• Completion: 2026-04-30
• First posted: 2025-09-11
• Last updated: 2025-09-19

Locations

1 site across 1 country: China