Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05986942

Enrollment

Registered

2023-08-14

Start date

2023-10-09

Completion date

2023-11-07

Last updated

2026-05-13

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

Conditions

Anxiety, Bleeding, Postoperative Pain

Keywords

Dexmedetomidine, tonsillectomy, adenoidectomy, postoperative anxiety

Brief 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. 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.

Interventions

DRUGDexmedetomidine

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.

DRUGFentanyl

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 design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

Healthy volunteers

Inclusion criteria

Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
postoperative pain	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	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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORYaşar G Gül

Medipol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026