A Study to Evaluate Aprepitant for the Prevention of Post Operative Nausea and Vomiting in Children (MK-0869-219)
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 6/11/2016 |
Start Date: | February 2013 |
End Date: | October 2016 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase IIb, Partially-Blinded, Randomized, Active Comparator- Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting
The purpose of this study is to determine the appropriate dosing regimen of aprepitant for
the prevention of post-operative nausea and vomiting in pediatric participants birth to 17
years.
the prevention of post-operative nausea and vomiting in pediatric participants birth to 17
years.
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
- Nasogastric or oral gastric tube intra- or post-operatively for suctioning
gastric contents
- 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
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