Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Maximum intensity of postoperative pain
研究概览
简要总结
Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative care is recommended for effective postoperative analgesia in children. However, intravenous ketoprofen doesn't have the marketing authorization for use in children less than 15 years old and its use is mainly justified by the absence of therapeutic alternatives. Recently, findings from published studies suggest that dexamethasone (DXM), which is actually recommended to prevent PONV for children "at risk", at a dose of 0.1mg/kg, would have analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).
Main objective :
To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).
Secondary objectives :
To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the consumption of rescue analgesics and the side effects in the first 24 hours after surgery.
详细描述
Methodology :
Non inferiority, phase III, therapeutic trial. Prospective, randomized double-blinded, monocentric study. Inclusion of 567 patients. Inclusion will be performed by the anesthesiologist, the day of surgery during the preoperative visit.
Each patient will be randomised to receive intraoperative DXM (0.2mg/kg), DXM (0.4mg/kg) (max 20mg) or ketoprofen (1mg/kg) (max 100mg).
The clinical data will be collected prospectively in an electronic database. If the hypothesis of non-inferiority is verified, it is planned to test the superiority of the hypothesis secondarily.
Treatment :
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, aged 1 to 16 years
- •Undergoing surgery (orchiopexy, inguinal hernia, circumcision, adenoidectomy, tonsillectomy or orthopedic act with osteosynthesis)
- •Parental consent
排除标准
- •Contraindication to NSAI or DXM
- •Hypersensitivity to ketoprofen, DXM, hypnovel or atarax
- •Porphyria
- •Long QT Syndrome
- •Renal or hepatic impairment
- •Corticosteroid consumption the week before surgery
- •NSAI consumption within 48 hours before surgery
- •IV induction for full stomach or myopathic patient.
- •French language not spoken by parents.
- •Simultaneous participation in biomedical research on health products
研究组 & 干预措施
Dexamethasone 0.2 mg/kg
Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.2 mg / kg after general anesthesia induction and before surgery incision.
干预措施: Dexamethasone 0.2 mg/kg (Drug)
Dexamethasone 0.4 mg/kg
Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.4 mg / kg after general anesthesia induction and before surgery incision.
干预措施: Dexamethasone 0.4 mg/kg (Drug)
Ketoprofen 1 mg/kg
Single injection of ketoprofen (Medac ketoprofen ® 100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and before surgery incision.
干预措施: Ketoprofen 1 mg/kg (Drug)
结局指标
主要结局
Maximum intensity of postoperative pain
时间窗: 1 hour
Maximum intensity of postoperative pain assessed in PACU using the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)
次要结局
- Side effects(24 hours)
- Rescue analgesic consumption(24 hours)
- Length of stay(24 hours)
- Intensity of postoperative pain(24 hours)
- Parent's satisfaction(24 hours)
- Pediatric Anesthesia Emergence Delirium Scale (PAEDS)(24 hours)