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临床试验/NCT06097169
NCT06097169已完成不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Dex

patients using dexmedetomidine infusion

干预措施: Dexmedetomidine (Drug)

Fen

patients using fentanyl for induction

干预措施: Fentanyl (Drug)

结局指标

主要结局

postoperative pain

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Omur

assistant professor

Medipol University

研究点 (1)

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