Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

Baskent University Ankara Hospital

Status and phase: Completed; Phase 4

Conditions: Comparison of the Effects of Propofol and Nasal Dexmedetomidine

Treatments: Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06466915

PedSed

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups

Group Dex

Experimental group

Description:

Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.

Treatment:

Drug: Dexmedetomidine

Group Pofol

Experimental group

Description:

Group Pofol received 1 mg/kg propofol IV before the extubation.

Treatment:

Drug: Propofol

Group PoDex

Experimental group

Description:

Group PoDex received 0.5 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended and 0.5 mg/kg propofol IV before the extubation.

Treatment:

Drug: Dexmedetomidine

Drug: Propofol