Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

NCT06466915 | Completed Phase 4

• 1 other identifier: PedSed
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Agitation-Delirium

  It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.

  0, 5, 10, 15, 20, 25, 30. minutes after extubation.

• Behavioral pain assessment

  It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.

  0, 5, 10, 15, 20, 25, 30. minutes after extubation.

Secondary Outcomes (2)

• Nausea-vomiting

  0, 5, 10, 15, 20, 25, 30. minutes after extubation.

• Rapid recovery

  30 minutes after extubation.

Study Arms (3)

Group Dex

EXPERIMENTAL

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

Drug: Dexmedetomidine

Group Pofol

EXPERIMENTAL

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

Drug: Propofol

Group PoDex

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Propofol

Interventions

Dexmedetomidine DRUG

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

Group Dex; Group PoDex

Propofol DRUG

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

Group PoDex; Group Pofol

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1-2

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Ahmed Uslu

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research assistant

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: June 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

TU (1)