Prevención de nauseas y vómitos postoperatorios en pacientes pediátricos. Prevention of Postoperative nausea and vomiting in pediatric patients. MedDRA version: 9.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting
Conditions
Interventions
Product Name: Aprepitant
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Aprepitant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmac
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate postoperative aprepitant plasma concentration profiles and pharmacokinetic parameters (AUC0-48, Cmax, Tmax, C24 hr, and C48 hr) obtained from infants 6 months to < 2 years of age and children 2 to < 6 years, 6 to < 12 years, and 12 to 17 years of age administered oral aprepitant preoperatively.;Secondary Objective: To evaluate the safety and tolerability of the administered dose(s) of aprepitant in patients 6 months to 17 years of age.;Primary end point(s): Pharmacokinectic Endpoint (Part I) Pharmacokinetic (PK) profile (AUC0-48, Cmax, Tmax, C24 hr, C48 hr) of the administered dose of aprepitant will be determined for patients aged 6 months to 17 years. Safety Endpoints:. Any, drug-related, serious, and serious drug-related adverse experience(s) during study therapy plus 14 days post therapy or drug-related adverse experience(s) leading to discontinuation of aprepitant therapy will be analyzed to assess tolerability.. Safety data will be assessed separately for each Part. | — |
Countries
Finland, Spain
Outcome results
None listed