Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417125
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-09
Brief Title:
Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children
Sponsor:
Fujian Provincial Hospital
Organization:
Fujian Provincial Hospital
Study Overview
Official Title:
Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 childrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None