Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
A randomized controlled trial evaluating the efficacy and safety of single-shot intraoperative methadone for postoperative pain in patients undergoing tonsillectomy. Fentanyl is used as an active comparator
详细描述
This study is an investigator-initiated, prospective, randomised controlled trial with two arms: an intervention arm (methadone) and a control arm (fentanyl). Patients scheduled for tonsillectomy at Randers Regional Hospital, Denmark, will be approached for study participation.
Patients are randomised in a 1:1 ratio in blocks of varying sizes (between 4 and 8) to receive either intraoperative methadone or fentanyl. The randomisation assignment will be handled by the hospital pharmacy using a web-based central randomisation procedure (www.sealedenvelope.com).
The study drug will be prepared by the hospital pharmacy at Aarhus University Hospital and delivered as kits with identical appearance, marked with the randomization number (1-130). On the day of surgery, a kit will be opened and a 10 ml syringe with study drug (methadone 2 mg/ml or fentanyl 30 microgram/ml or ) will prepared by a health care professional (nurse or medical doctor not involved in the study or the treatment of patients). Once prepared, the blinded study drug will be given to and handled by one of the research team members and administered after induction of anesthesia and prior to surgery
The dose of the study drug will be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg / 3 μg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (women: height (cm) - 105. Men: height (cm) - 100)) after induction of anaesthesia and before the start of surgery.
Postoperative data will be obtained by reviewing hospital records, by interview and electronic questionnaires sent by email.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients (≥18 years) scheduled for elective tonsillectomy
排除标准
- •American Society of Anaesthesiologists (ASA) physical status IV or V
- •Allergy to study drugs
- •Daily use of opioids 7 days prior to surgery
- •Inability to provide informed consent
- •Severe respiratory insufficiency
- •Heart failure
- •Acute alcohol intoxication/delirium tremens
- •Increased intracranial pressure
- •Acute liver disease
- •Liver insufficiency
- •Kidney insufficiency
- •Treatment with rifampicin
- •Treatment with any drug prolonging the QT-interval
- •Pregnancy (every female not using contraceptives will be screened with urine human choriogonadotropin)
- •Breastfeeding
研究组 & 干预措施
Methadone
Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively
干预措施: Methadone (Drug)
Fentanyl
Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively
干预措施: Fentanyl (Drug)
结局指标
主要结局
Postoperative pain
时间窗: On arrival at the post-anesthesia care unit
Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)
Opioid consumption
时间窗: First 5 postoperative days
Cumulative postoperative opioid consumption in morphine equivalents
次要结局
- Postoperative pain(1, 2, 3, 5 and 7 days after surgery)
- Opioid consumption(1 and 7 days after surgery)
- Postoperative nausea and vomiting (none, mild, moderate, severe)(1, 2 and 3 days after surgery)
- Sedation(4 hours after surgery)