The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patients consumption of analgesics in the PACU.
研究概览
简要总结
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.
详细描述
Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals.
In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.
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)
盲法说明
Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
入排标准
- 年龄范围
- 0 Years 至 4 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.
排除标准
- •Age =/> 5 years at the date of operation
- •Born preterm (Before gestational age of 37 weeks)
- •Congenital heart disease
- •Previous scrotal surgery
- •Laparoscopic operation
- •American Society of Anaesthesiologists (ASA) physical status lll, IV or V
- •Allergy to study drugs
- •Preoperative daily use of opioids
- •Parents with inability to provide informed consent
- •Severe respiratory insufficiency
- •Acute abdominal pain
- •Severe kidney insufficiency
- •Treatment with rifampicin
研究组 & 干预措施
Placebo
A 5 ml syringe with saline will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.
干预措施: Placebo (Other)
Methadone
A 5 ml syringe with 1 mg/ml of methadone will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.
干预措施: Methadone Hydrochloride (Drug)
结局指标
主要结局
Patients consumption of analgesics in the PACU.
时间窗: 3 hours
Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).
Pain intensity (highest score)
时间窗: 3 hours
FLACC-score - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score. Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours)
次要结局
- Readiness to discharge(6 hours)
- Unscheduled parental contacts to the hospital(4 days)
- Analgesic consumption following discharge until evening on the first postoperative day(36 hours)
- Pain intensity the first postoperative day(48 hours)
- Patients need of supplemental oxygen in PACU(3 hours)
- Awakenings during the first night after discharge.(24 hours)