Clinical trial NCT06466915: Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium
Official title: Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Comparison of the Effects of Propofol and Nasal Dexmedetomidine
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 162
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dental pain and anxiety are quite common in pediatric patients. However, due to children's 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 child's 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 child's 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.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* Cardiac disease,
* Psychiatric disease,
* Coronary artery disease,
* Long-term sedative drug use,
* Pulmonary disease,
* Known allergy to planned drugs

Primary outcomes:
measure: Agitation-Delirium
timeFrame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
measure: Behavioral pain assessment
timeFrame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
Secondary outcomes:
measure: Nausea-vomiting
timeFrame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
measure: Rapid recovery
timeFrame: 30 minutes after extubation.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ahmed Uslu
state: Çankaya
Study officials:
References: