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

Completed

• Conditions: Anxiety; Postoperative Pain; Bleeding
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT05986942
• Lead Sponsor: Burak Omur

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-10-09
• Status Verified: 2023-11
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dex	Dexmedetomidine	patients using dexmedetomidine infusion
Fen	Fentanyl	patients using fentanyl for induction

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Turkey