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

NCT07168720 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Guangzhou Novaken Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2026-03-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168720 on ClinicalTrials.gov