Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures
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
- 否
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
piroxicam group who received induction with piroxicam(0.4mg/kg) IM
干预措施: Piroxicam group (Drug)
placebo
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
Hoda Shokri
Associate professor of Anesthesia
Ain Shams University
