Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Pain score (VAS) 2, 4, and 24 hours postoperatively.
研究概览
简要总结
Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
详细描述
We will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. Outcomes include amount of morphine and ketobemidone used, and pain measured on a VAS scale. Side-effects, e.g., PONV, dizziness and sedation are also measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for benign tonsillectomy
- •Between the ages of 18 and 50 years old
- •ASA 1-2 and a surgical technique without the need for local anaesthetics or electrical scissors
排除标准
- •Malignancy
- •Patients who are unable to cooperate
- •Does not speak Danish
- •Has allergy for drugs used in the trial
- •Has abused drugs and/or medicine
- •Diabetes treated with medicine
- •Treatment with systemic steroids 4 weeks prior to the operation
- •Daily use of antacids
- •Daily use of analgesics
- •Use of antidepressives
- •Known kidney disease
- •Pregnancy
研究组 & 干预措施
Paracetamol
Oral paracetamol 1 g + placebo + placebo
干预措施: paracetamol + placebo + placebo (Drug)
Paracetamol + Pregabalin
Oral paracetamol 1g + oral pregabalin 300 mg + placebo
干预措施: paracetamol + pregabalin + placebo (Drug)
Paracetamol + pregabalin + dexamethasone
Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg
干预措施: paracetamol + pregabalin + dexamethasone (Drug)
结局指标
主要结局
Pain score (VAS) 2, 4, and 24 hours postoperatively.
时间窗: 0-24 hours
Both at rest and when swallowing 50 ml of water.
时间窗: 0-24 hours
次要结局
- Total amount of morphine and ketobemidone used 0-24 hours postoperatively.(0-24 hours)
- Nausea and vomiting 2, 4, and 24 hours postoperatively.(0-24 hours)
- Dizziness and sedation 2, 4, and 24 hours postoperatively.(0-24 hours)