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临床试验/NCT05288374
NCT05288374已完成4 期

Celecoxib for Treatment of Postoperative Pain After Osteosynthesis of Distal Radius Fracture

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Postoperative pain intensity

研究概览

简要总结

Patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (PO) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. After surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (IV) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (NRS) of 0-10, piritramid 15 mg intramuscularly (IM) will be administered. Pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.

详细描述

A prospective single-blinded randomized study will be performed in patients of the Orthopaedic Clinic of the 3rd Medical Faculty of Charles University (3LF UK) and the Faculty Hospital Kralovske Vinohrady (FHKV) scheduled for elective osteosynthesis of the distal radius. The expected number of participants is 25 in each arm of the study. They will be randomized by envelope method into an non-steroidal analgesic (NSA) group, which will receive celecoxib at 6 in the morning before surgery, and a C group, which will receive a placebo pill prepared by the hospital pharmacy. General anesthesia will be performed in both groups in the standard way using propofol, sufentanil and sevoflurane 1 minimal alveolar concentration (MAC) with air and oxygen at 40% concentration. At the end of surgery, each patient will be given paracetamol 1 g intravenously (IV) and ondansetron 4 mg IV. Pain intensity after surgery will be measured on a numerical rating scale (NRS) 0-10. For postoperative analgesia, both groups will receive paracetamol 1 g IV. every 6 hours, and for NRS>4 pain intensity, piritramid 15 mg intramuscularly (IM). The NSA group will receive celecoxib 100 mg orally (PO) at 6 in the morning and 6 in the afternoon, and group C will receive placebo at the same interval.

Parameters to be monitored will be postoperative pain intensity for the primary objective, and opioid piritramid consumption and side effects of the treatment for the secondary objectives. NRS, number of doses of piritramid and side effects will be recorded in a coded questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Placebo pill provided by a hospital pharmacy will be administered orally on the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for osteosynthesis of distal radius fracture

排除标准

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  • Patients who have demonstrated allergic-type reactions to sulfonamides.
  • Inability to understand the questionnaire

研究组 & 干预措施

Celecoxib

Experimental

Celecoxib 100 mg orally will be administered in the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.

干预措施: Celecoxib 100 mg (Drug)

Placebo

Placebo Comparator

A placebo pill provided by a hospital pharmacy will be administered in the day of surgery at 6 in the morning and 6 in the afternoon for 3 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Postoperative pain intensity

时间窗: up to 2 days

Intensity of pain measured by numeric rating scale (NRS) 0-10

次要结局

  • Number of piritramid injection(3 days)
  • Side effects of treatment(3 days)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiri Malek

Assoc. Prof. Jiri Malek, MD, Ph.D.

Charles University, Czech Republic

研究点 (2)

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