Clinical Trial: Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Comparison of Aprepitant PO and Ondansetron IV for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Orthognathic Surgery and General Anesthesi
Brief Summary:
Postoperative nausea and vomiting (PONV) persists as one of the more common complications of surgery. Although rarely life-threatening, it is the postoperative outcome that is most unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or congenital malformations. The bones of the face and jaws are cut and placed in a new position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly challenging to the patient as their jaws are kept closed together with wires or elastic bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving and puts them at risk for fluid in their lungs.
Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing PONV and nausea severity after open abdominal surgery. From this study, the FDA approved the use of aprepitant for PONV prevention in patients >18 years of age. Gan suggested further investigation in different populations.
Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic surgery.
Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require hospital admission for at least one night. We will exclude patients who are currently taking medications that have interactions with aprepitant (pimozide, terfenadine, astemizole, cisapride), those who have a known vomiting disorder such as bulimia, and those who have vomited for any reason within 24 hours of surgery. The procedure will be performed by 5 surgeo
Detailed Summary:
Sponsor: Northwell Health
Current Primary Outcome: No vomiting and use of rescue medications [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- no nausea based on verbal rating scale [ Time Frame: 0, 2, 6, 24 hours ]
- time to first emetic episode [ Time Frame: 24 hours ]
- time to use of rescue medications [ Time Frame: 24 hours ]
Original Secondary Outcome: Same as current
Information By: Northwell Health
Dates:
Date Received: June 16, 2008
Date Started: June 2008
Date Completion:
Last Updated: August 8, 2013
Last Verified: August 2013
