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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06466915
Enrollment
162
Registered
2024-06-20
Start date
2024-07-01
Completion date
2025-04-30
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of the Effects of Propofol and Nasal Dexmedetomidine

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.

Interventions

DRUGDexmedetomidine

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

DRUGPropofol

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

Sponsors

Baskent University Ankara Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Agitation-Delirium0, 5, 10, 15, 20, 25, 30. minutes after extubation.It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.
Behavioral pain assessment0, 5, 10, 15, 20, 25, 30. minutes after extubation.It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.

Secondary

MeasureTime frameDescription
Nausea-vomiting0, 5, 10, 15, 20, 25, 30. minutes after extubation.It will be evaluated by visual analogue scale.
Rapid recovery30 minutes after extubation.It will be evaluated with a Modified Aldrete Score.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026