NCT00878228

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).

Conditions

• Nausea and Vomiting, Postoperative

Interventions

Type	Name	Description
DRUG	Ondansetron	The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.
DRUG	Placebo	The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2009-04-08
• Last updated: 2013-01-31
• Results posted: 2012-08-28

Locations

1 site across 1 country: United States