Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

NCT ID: NCT06466915

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-04-30

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.

Conditions

Comparison of the Effects of Propofol and Nasal Dexmedetomidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group Dex

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Group Pofol

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Group PoDex

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baskent University Ankara Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Uslu

MD, Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Uslu

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PedSed

Identifier Type: -

Identifier Source: org_study_id