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OpenTrials
Completed

NCT Number: NCT05986942

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Bleeding Hemorrhage Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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.

Other names: Talinat

Dexmedetomidine

Drug

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.

Other names: Precedex

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Burak Omur

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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