AnxietyNCT06097169
Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment
An observational study of Anxiety and Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Anxiety, Postoperative Pain, Nausea
- What is being tested?
- Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 25 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included
Who may be able to join
- Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.
Who cannot join
- developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.
- Conditions
- Anxiety, Postoperative Pain, Nausea
- Being tested
- Fentanyl, Dexmedetomidine
- Keywords
- Dexmedetomidin, dental treatment, post operative anxiety
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Talinat
In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
DexmedetomidineDrug
Also called Precedex
In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
| Study group | Role | What they receive |
|---|---|---|
| Dex | patients using dexmedetomidine infusion Receives: Drug: Dexmedetomidine | |
| Fen | patients using fentanyl for induction Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.
Measured: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
postoperative anxiety
Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.
Measured: anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Oct 2023
- Primary completion20 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097169
- Sponsor's protocol ID
- E-10840098-772.02-6155
- Status last verified
- Feb 2024
- First submitted
- 18 Oct 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou D, Yang XD, Wu HY, Xiong GL, Wang LK. Determination of the ED90 of Dexmedetomidine Infusion to Prevent Emergence Agitation in Children Undergoing Dental Rehabilitation With Sevoflurane Anesthesia: A Biased-Coin Up-and-Down Sequential Allocation Trial. Anesth Analg. 2024 Oct 1;139(4):761-769. doi: 10.1213/ANE.0000000000006626. Epub 2024 Jul 21.
PubMed 37478025
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment
- ClinicalTrials.gov ID
- NCT06097169
- Acronym / sponsor ID
- E-10840098-772.02-6155
- Conditions
- Anxiety, Postoperative Pain, Nausea
- Keywords
- Dexmedetomidin, dental treatment, post operative anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex | – | Drug: Dexmedetomidinepatients using dexmedetomidine infusion |
| Fen | – | Drug: Fentanylpatients using fentanyl for induction |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included
Key inclusion criteria (1 listed)
- Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.
Key exclusion criteria (1 listed)
- developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies
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 |
|---|---|---|
| FentanylAlso: TalinatIn Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen. | Drug | Fen |
| DexmedetomidineAlso: PrecedexIn Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen. | Drug | Dex |
Primary outcome
postoperative pain
Time frame: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.
postoperative anxiety
Time frame: anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.
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 29 Feb 2024.
- Background: PubMed 37478025Zhou D, Yang XD, Wu HY, Xiong GL, Wang LK. Determination of the ED90 of Dexmedetomidine Infusion to Prevent Emergence Agitation in Children Undergoing Dental Rehabilitation With Sevoflurane Anesthesia: A Biased-Coin Up-and-Down Sequential Allocation Trial. Anesth Analg. 2024 Oct 1;139(4):761-769. doi: 10.1213/ANE.0000000000006626. Epub 2024 Jul 21.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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?
An observational study of Anxiety and Postoperative Pain, run by Medipol University 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 1 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 29 Feb 2024. 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.
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?
postoperative pain (time frame: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.). 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?
On the ClinicalTrials.gov record for NCT06097169, which also lists 1 linked publication.
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 29 Feb 2024.