Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466915
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
Propofol vs Nasal Dexmedetomidine in Pediatric Agitation and Delirium
Sponsor:
Baskent University Ankara Hospital
Organization:
Baskent University Ankara Hospital
Study Overview
Official Title:
Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Dental pain and anxiety are quite common in pediatric patients However due to childrens inability to express their fears and lack of knowledge about the procedures to be performed these symptoms have often been misunderstood and inadequately treated in pediatric settings Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia Emergence anxiety can be harmful to the patient leading to bleeding at the surgical site displacement of intravenous catheters parental anxiety additional care needs and delays in hospital discharge Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery However inhalation anesthetics often lead to a high rate of emergence anxiety ranging from 25 to 80 depending on the scoring scale used the childs age and the type of surgery performed Additional sedative or analgesic drugs such as midazolam dexmedetomidine or propofol have been used to prevent emergence anxiety
Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects but it can cause mild respiratory depression Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression However although intranasal dexmedetomidine initially has relatively rapid absorption the absorption process may take longer compared to intravenous administration implying that the childs hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety
The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice
Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects but it can cause mild respiratory depression Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression However although intranasal dexmedetomidine initially has relatively rapid absorption the absorption process may take longer compared to intravenous administration implying that the childs hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety
The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None