Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures

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.

Study Overview

• Status: Completed
• Conditions: Comparison of the Effects of Propofol and Nasal Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06490
      • Ahmed Uslu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Dex; Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.	Drug: Dexmedetomidine; Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.
Experimental: Group Pofol; Group Pofol received 1 mg/kg propofol IV before the extubation.	Drug: Propofol; Group Pofol received 1 mg/kg propofol IV before the extubation.
Experimental: 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.	Drug: Dexmedetomidine; Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.; Drug: Propofol; Group Pofol received 1 mg/kg propofol IV before the extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea-vomiting	It will be evaluated by visual analogue scale.	0, 5, 10, 15, 20, 25, 30. minutes after extubation.
Rapid recovery	It will be evaluated with a Modified Aldrete Score.	30 minutes after extubation.

Collaborators and Investigators

• Sponsor: Baskent University Ankara Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Propofol
• Other Study ID Numbers: PedSed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes