A Study of Aprepitant (MK0869) in Pediatric Participants Undergoing Surgery (0869-148 AM1)

This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.

• Drug: aprepitant
  Adolescent Dose (12-17 years): 40 mg powder reconstituted to total volume of 5 mL of water, administered orally, as a single dose 1-3 hours before expected induction of anesthesia *Dosing for children under 12 years old will be based on body weight (15 mg + 1.1 mg/kg)
  Other Name: Emend
• Drug: Comparator: Ondansetron
  Single dose administration of ondansetron, 0.1 mg/kg up to 4mg by IV immediately prior to induction of anesthesia
  Other Name: Zofran

• Experimental: Part I - Arm 1
  Aprepitant (non-randomized, open label)
  Intervention: Drug: aprepitant
• Experimental: Part II - Arm 1
  Aprepitant and Ondansetron placebo
  Intervention: Drug: aprepitant
• Active Comparator: Part II - Arm 2
  Ondansetron and Aprepitant placebo
  Intervention: Drug: Comparator: Ondansetron

Inclusion Criteria:

• Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part II) hospital stay
• Participant is scheduled to receive general anesthesia
• Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
• Female participants of childbearing potential must have negative pregnancy test prior to drug administration
• A female participant who is of reproductive potential must agree to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
• Participant weighs 6 kg or more

Exclusion Criteria:

• Participant is undergoing surgery for a life-threatening condition
• Participant is pregnant or breast feeding
• Participant has vomited within 24 hours prior to surgery
• Participant has a known history of QT prolongation or is currently taking other medicinal products that lead to QT prolongation
• Participant has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction), evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid obesity, that might pose unwarranted risk