Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy (PDNV)
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).
Nausea and Vomiting, Postoperative
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy|
- Incidence of Nausea [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]Percentage of participants with nausea
- Severity of Nausea [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]Percentage of participants reporting moderate or severe nausea in the first 24 hours
- Impact of Nausea and Vomiting on Quality of Life [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]Percentage of participants whose quality of life was impacted by nausea and vomiting
|Study Start Date:||April 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Study Group
The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
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.
Other Name: Zofran
Placebo Comparator: Control Group
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878228
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jacques YaDeau, MD, PhD||Hosptial for Special Surgery|