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).
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
- Conditions the study is for
- Comparison of the Effects of Propofol and Nasal Dexmedetomidine
- 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
- Are there results?
- None posted in the registry
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.
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.
- Being tested
- Dexmedetomidine, Propofol
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 group | Role | What they receive |
|---|---|---|
| Group Dex | Experimental | Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended. Receives: Drug: Dexmedetomidine |
| Group Pofol | Experimental | Group Pofol received 1 mg/kg propofol IV before the extubation. Receives: 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. Receives: Drug: Dexmedetomidine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation-Delirium
It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.
Measured: 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.
Measured: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
Secondary outcomes (2)
Nausea-vomiting
It will be evaluated by visual analogue scale.
Measured: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
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.
- First posted20 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of the Effects of Propofol and Nasal DexmedetomidineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Uslu, Baskent University Ankara Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures
- ClinicalTrials.gov ID
- NCT06466915
- Acronym / sponsor ID
- PedSed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Dex | Experimental | Drug: DexmedetomidineGroup Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended. |
| Group Pofol | Experimental | Drug: PropofolGroup Pofol received 1 mg/kg propofol IV before the extubation. |
| Group PoDex | Experimental | Drug: Dexmedetomidine, Drug: PropofolGroup 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. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA 1-2
Key exclusion criteria (6 listed)
- Cardiac disease,
- Psychiatric disease,
- Coronary artery disease,
- Long-term sedative drug use,
- Pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineGroup Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended. | Drug | Group Dex, Group PoDex |
| PropofolGroup Pofol received 1 mg/kg propofol IV before the extubation. | Drug | Group PoDex, Group Pofol |
Primary outcome
Agitation-Delirium
Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.
Behavioral pain assessment
Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.
2 secondary outcomes
Nausea-vomiting
Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
Rapid recovery
Time frame: 30 minutes after extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation-Delirium (time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.