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Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
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
Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children. Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children. This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.
Age
2 - 5 years
Sex
ALL
Healthy Volunteers
No
Fujian Provincial Hospital
Fuzhou, Fujian, China
Start Date
May 22, 2024
Primary Completion Date
September 22, 2025
Completion Date
October 21, 2025
Last Updated
December 22, 2025
324
ACTUAL participants
Dexmedetomidine Hydrochloride
DRUG
Midazolam
DRUG
normal Saline
DRUG
Glucose solution
DRUG
Lead Sponsor
Fujian Provincial Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06876246