The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- change in postoperative intravenous opioid dose
研究概览
简要总结
The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively.
Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.
详细描述
Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h. Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20 hours postoperatively.
After surgery optional rescue analgesia is given on patient request: either tramadol in a dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with morphine, as indicated according to the standard of care. Patients are evaluated up till 24 hours postoperatively. After that patients are followed up as long as indicated per standard of care.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively.
- •physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2
- •Signed written informed consent by parents/official caregivers.
排除标准
- •Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
- •oncologic disease
- •central nervous system disease
- •renal dysfunction
- •hepatic dysfunction
- •bronchial asthma
- •ulcer(s) in gastrointestinal system
- •hemorrhagic diathesis
- •chronic use of NSAIDs
- •chronic use of opioids
- •chronic use of anticoagulants
- •female patient is known to be pregnant
研究组 & 干预措施
paracetamol and ketoprofen
paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Paracetamol (Drug)
paracetamol and ketoprofen
paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Ketoprofen (Drug)
paracetamol and ketoprofen
paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Tramadol (Drug)
paracetamol and ketoprofen
paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Morphine (Drug)
placebo and ketoprofen
0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Placebo (for paracetamol) (Drug)
placebo and ketoprofen
0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Ketoprofen (Drug)
placebo and ketoprofen
0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Tramadol (Drug)
placebo and ketoprofen
0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter.
ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.
干预措施: Morphine (Drug)
结局指标
主要结局
change in postoperative intravenous opioid dose
时间窗: 24 hours postoperatively
次要结局
- change in pain level (analgesia) assessed by 10 point pain scales(24 hours postoperatively)
研究者
Danguole C Rugyte
MD, PhD
Lithuanian University of Health Sciences