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Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children
Sponsor: Fujian Provincial Hospital
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
Conditions
Interventions
Dexmedetomidine Hydrochloride
Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.
Midazolam
Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.
normal Saline
Patients were premedicated with normal saline 0.02 mL/kg in the holding area.
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