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Clinical Trials/NCT05986942
NCT05986942
Completed
Not Applicable

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

Burak Omur1 site in 1 country80 target enrollmentOctober 9, 2023

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Anxiety
Sponsor
Burak Omur
Enrollment
80
Locations
1
Primary Endpoint
postoperative pain
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2023
End Date
November 7, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Burak Omur
Responsible Party
Sponsor Investigator
Principal Investigator

Burak Omur

assistant professor

Medipol University

Eligibility Criteria

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

Arms & Interventions

Dex

patients using dexmedetomidine infusion

Intervention: Dexmedetomidine

Fen

patients using fentanyl for induction

Intervention: Fentanyl

Outcomes

Primary Outcomes

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.

Study Sites (1)

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