The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Preventing of postoperative nausea and vomiting
研究概览
简要总结
The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.
详细描述
One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (the classification of the American Society of Anesthesiologists) physical status I-II
- •Patients who scheduled for elective maxillofacial surgery under general anesthesia
排除标准
- •Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol)
- •History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases
- •Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery
研究组 & 干预措施
Perfalgan
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
干预措施: Perfalgan (Drug)
Perfalgan
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
干预措施: Control (Drug)
Control
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
干预措施: Perfalgan (Drug)
Control
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
干预措施: Control (Drug)
结局指标
主要结局
Preventing of postoperative nausea and vomiting
时间窗: First 24 hours postoperatively
Preventing of postoperative nausea and vomiting in postoperative care unit
次要结局
未报告次要终点
研究者
Ozlem Kocaturk
Faculty of Dentisty Oral and Maxillofacial Surgery
Aydin Adnan Menderes University