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Comparison of the Effects of Propofol and Nasal DexmedetomidinePhase 4NCT06466915

Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

A Phase 4 study testing Dexmedetomidine and Propofol in people with Comparison of the Effects of Propofol and Nasal Dexmedetomidine, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 8 yearsHealthy volunteers can take part
What is being tested?
Dexmedetomidine and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 30 Apr 2025
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • ASA 1-2

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahmed Uslu

    Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

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

  • PropofolDrug

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

Study groups in NCT06466915
Study groupRoleWhat they receive
Group DexExperimentalGroup Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.
Receives: Drug: Dexmedetomidine
Group PofolExperimentalGroup Pofol received 1 mg/kg propofol IV before the extubation.
Receives: Drug: Propofol
Group PoDexExperimentalGroup 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.
Receives: Drug: Dexmedetomidine; Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agitation-Delirium

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

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

  2. Behavioral pain assessment

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

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

Secondary outcomes (2)
  1. Nausea-vomiting

    It will be evaluated by visual analogue scale.

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

  2. Rapid recovery

    It will be evaluated with a Modified Aldrete Score.

    Measured: 30 minutes after extubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466915
Sponsor's protocol ID
PedSed
Status last verified
Jul 2026
First submitted
14 Jun 2024
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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