A Study of Aprepitant in Pediatric Patients Undergoing Surgery

• Conditions: MedDRA version: 14.0Level: LLTClassification code 10036901Term: Prophylaxis against postoperative nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]; Prevention of Postoperative nausea and vomiting in pediatric patients.

• Registration Number: EUCTR2008-003178-17-Outside-EU/EEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 92

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: 92
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified