Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy (PDNV)
|ClinicalTrials.gov Identifier: NCT00878228|
Recruitment Status : Completed
First Posted : April 8, 2009
Results First Posted : August 28, 2012
Last Update Posted : January 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Nausea and Vomiting, Postoperative||Drug: Ondansetron Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy|
|Study Start Date :||April 2009|
|Primary Completion Date :||January 2010|
|Study Completion Date :||February 2010|
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.
- Incidence of Nausea [ Time Frame: Postdischarge Day 1 ]Percentage of participants with nausea
- Severity of Nausea [ Time Frame: Postdischarge Day 1 ]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 ]Percentage of participants whose quality of life was impacted by nausea and vomiting
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|