Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06417125
PHASE4

Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children

Sponsor: Fujian Provincial Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are: * Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam? * Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium. Participants will: * Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication * Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30

Official title: Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

2 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2024-05-22

Completion Date

2025-10-21

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine Hydrochloride

Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.

DRUG

Midazolam

Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.

DRUG

normal Saline

Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

DRUG

Glucose solution

Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Locations (1)

Fujian Provincial Hospital

Fuzhou, Fujian, China