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临床试验/NCT04062591
NCT04062591已完成早期 1 期

Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures

Ain Shams University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年8月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
72
试验地点
1
主要终点
rescue dose of analgesic

研究概览

简要总结

At Eldemerdash Hospital at Ain Shams University in Egypt, 72 adult patients (16 to 25 years old) who had mandibular or maxillary fractures were treated with open reduction and internal stabilization. Patients were divided into two categories. (31 patients each) Using randomly generated data from computer, the piroxicam group received 0.4 mg/kg of intramuscular piroxicam, while the general anesthesia group (GA group) did not receive piroxicam.

The overall amount of rescue analgesic dosage and postoperative complications like nausea and vomiting were therefore included in the outcomes measurement.

详细描述

Patients were divided into two groups at random using a computer-generated list: the GA group received no piroxicam and the piroxicam group got a 0.4 mg/kg IM piroxicam induction. Both groups got IV paracetamol (24 mg/kg slowly administered over 20 minutes).

Fentanyl 2 micrograms/kg was administered after general anesthesia was induced and venous access was established. A suitable size endotracheal tube was then placed intranasal, and intubation was aided by Atracurium (0.5 mg/kg). Throughout the operation, 1 MAC isoflurane in a mixture of 50% air and oxygen was used to maintain anesthesia in all patients who were mechanically ventilated in pressure-controlled mode with targeted EtCO2 (30-35 mmHg). An oral pack was also introduced.

After the operation general anesthesia was stopped and the endotracheal tube was removed, Neostigmine 50 mg/kg and atropine sulfate 15 mg/kg were used to reverse muscle relaxation. Patient transportation was made to the post-anesthesia care unit (PACU). Postoperative analgesia was evaluated by a blind investigator using 10 cm- visual analogue scale score which had been explained to the patient on the preoperative visit where: 0 = no pain, 10 = worst possible pain) in the PACU then at 3, 6, 12, 24 hours, if the pain score >3, pethidine 25 mg intravenously and Ondansetron 0.1mg/kg was used for cases with nausea or vomiting.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged from 16-25 years old
  • scheduled for open reduction and internal fixation of mandibular or maxillary fractures

排除标准

  • a history of convulsion,
  • gastrodudenal ulcer
  • hematological disorders
  • patient suffering from hepatic or renal dysfunction
  • concomitant use of anticoagulants
  • refusal of the patients to participate
  • patients younger than 12 years

研究组 & 干预措施

piroxicam

Active Comparator

piroxicam group who received induction with piroxicam(0.4mg/kg) IM

干预措施: Piroxicam group (Drug)

placebo

Sham Comparator

saline IM in the same dose of piroxicam

干预措施: Placebo (Drug)

结局指标

主要结局

rescue dose of analgesic

时间窗: 24 hours

patients needed additional doses of rescue analgesic

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hoda Shokri

Associate professor of Anesthesia

Ain Shams University

研究点 (1)

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