EUCTR2008-003178-17-ES进行中（未招募）1 期
Estudio multicéntrico de 2 partes para evaluar la farmacocinética, la seguridad y la tolerabilidad del aprepitant en pacientes pediátricos sometidos a una intervención quirúrgica.A Multicenter, 2-Part Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients are 6 months to 17 years of age at the time of study entry
- •2. Patient is scheduled to undergo surgery (such as but not limited to abdominal, pelvic, perineal, plastic surgery to repair physical deformity, or orthopedic surgery) requiring a 48 hour hospital stay after the end of surgery.
- •3. Patient weighs >= 6 kg and has an American Society of anesthesia (ASA) physical status of I-III.
- •4. Patient is scheduled to receive postoperative opioids (e.g., morphine, or fentanyl) by oral, rectal, intramuscular (IM) or IV administration, or patient controlled analgesia (PCA).
- •5. Patient is scheduled to receive general anesthesia with the following general anesthetic regimen:
- •- Induction with any inhaled anesthetic agent
- •- Opioids (e.g., fentanyl, morphine, or hydromorphone
- •6. Patient has an existing vascular catheter (peripheral or central) prior to receiving aprepitant
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is undergoing surgery for a life threatening condition.
- •2. Placement of nasogastric or oral gastric tube intra- or postoperatively. (Patients should be excluded if a nasogastric or oral gastric tube is routinely used for the type of surgery to be performed.
- •3. Patient is scheduled to receive propofol for maintenance of anesthesia. (Note: propofol is permitted for induction of anesthesia in addition to an inhaled anesthetic agent.)
- •4. Patient is taking, or has taken within 7 days of surgery the following cytochrome:
- •P450 3A4(CYP3A4) substrates:Terfenadine, Cisapride, Astemizole, Pimozide
- •5. Patient is taking, or has taken within 7 days of surgery the following CYP3A4 inhibitors:
- •? Clarithromycin, erythromycin, ketoconazole, itraconazole ,fluconazole or telithromycin
- •6. Patient is taking, or has taken within 30 days of surgery the following CYP3A4 inducers:
- •? Phenytoin or carbamazepine, barbiturates, rifampicin or rifabutin, St. John's Wort
- •7. Patient is allergic to scheduled preoperative tranquilizer, operative anesthetics,
- •postoperative analgesia, ondansetron or any 5HT3 antagonist, or aprepitant.
- •8. Patient is expected to receive neuroaxial anesthesia such as epidural, spinal or caudal anesthesia. (Patients should be excluded if neuroaxial anesthesia is routinely used for the type of surgery to be performed.
- •9. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with another NK-1 antagonist, or has taken a non-approved (investigational) drug within the last 4 weeks.
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