A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)
Condition: Post-operative Nausea; Post-operative Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant; Placebo to Aprepitant; Ondansetron; Placebo to match ondansetron
Intervention description: Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.; Administered IV at a dose of 4 mg for participants >40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants <1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.; Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.
Intervention MeSH terms: Ondansetron; Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: This study will be conducted as a partially blinded study. PK samples will not be collected from participants in the control group. To maintain a partial blind, approximately 3 participants randomly selected from each age group in each of the aprepitant treatment groups will not have PK sampling. All participants will remain blinded to the study treatment. The investigator and Sponsor will be blinded to the study medication in participants not providing PK samples. The investigator and Sponsor will remain blinded to the aprepitant dose given to participants from whom PK samples will be collected.
Enrollment: 229.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric
      participants.

      Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental
      analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using
      population PK modeling and simulation will be described in a separate report.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of
             weight

          -  Scheduled to receive general anesthesia AND must have at least one of the following
             risk factors for post-operative nausea and vomiting (PONV) in addition to receiving
             general anesthesia:

               1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy,
                  adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or
                  herniorraphy; OR

               2. scheduled to have an operative procedure associated with PONV: intraoperative
                  opioid use or anticipated opioid administration within the first 24 hours
                  following surgery.

        Exclusion Criteria:

          -  Emergency surgery for a life-threatening condition

          -  Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is
             permitted for induction of anesthesia).

          -  Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or

        benzodiazepine antagonists (e.g., flumazenil)

          -  Scheduled to undergo cardiac or neurosurgery

          -  Vomiting caused by any organic etiology (such as gastric outlet

        obstruction or small bowel obstruction)

          -  Vomiting within 24 hours prior to surgery

          -  Participant had a nasogastric or oral gastric tube intra- or post-operatively for
             suctioning gastric contents (note: nasogastric or oral gastric tube intra- or
             post-operatively could only be used for feeding. Participants were to be excluded if a
             nasogastric or oral gastric tube for suctioning was routinely used for the type of
             surgery being performed)

          -  Active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any
             uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction)
             except for malignancy, or a history of any illness which in the opinion of the
             investigator, might confound the results of the study or pose unwarranted risk to the
             participant

          -  Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse