AnxietyNCT05986942
Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy
An observational study of Anxiety and Postoperative Pain, run by Burak Omur 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, Bleeding
- What is being tested?
- Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2023to 7 Nov 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
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, Bleeding
- Being tested
- Fentanyl, Dexmedetomidine
- Keywords
- Dexmedetomidine, tonsillectomy, adenoidectomy, postoperative anxiety
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Hemorrhage
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 posted14 Aug 2023
- Study start9 Oct 2023
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Burak Omur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burak Omur, Medipol University
- Investigators
- Yaşar G Gül, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986942
- Sponsor's protocol ID
- 000030195314317
- Status last verified
- May 2026
- First submitted
- 26 Jul 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
PubMed 20705788Lin R, Ansermino JM. Dexmedetomidine in paediatric anaesthesia. BJA Educ. 2020 Oct;20(10):348-353. doi: 10.1016/j.bjae.2020.05.004. Epub 2020 Jul 22. No abstract available.
PubMed 33456916