Trial Outcomes & Findings for Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy (NCT NCT00878228)
NCT ID: NCT00878228
Last Updated: 2013-01-31
Results Overview
Percentage of participants with nausea
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Postdischarge Day 1
Results posted on
2013-01-31
Participant Flow
Participant milestones
| Measure |
Study Group
The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
Control Group
The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
Baseline characteristics by cohort
| Measure |
Study Group
n=39 Participants
The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
Control Group
n=37 Participants
The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42 years
STANDARD_DEVIATION 14 • n=5 Participants
|
37 years
STANDARD_DEVIATION 11 • n=7 Participants
|
39 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postdischarge Day 1Percentage of participants with nausea
Outcome measures
| Measure |
Study Group
n=39 Participants
The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
Control Group
n=37 Participants
The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
|---|---|---|
|
Incidence of Nausea
|
46 percentage of participants
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: Postdischarge Day 1Percentage of participants reporting moderate or severe nausea in the first 24 hours
Outcome measures
| Measure |
Study Group
n=39 Participants
The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
Control Group
n=37 Participants
The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
|---|---|---|
|
Severity of Nausea
|
23 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: Postdischarge Day 1Percentage of participants whose quality of life was impacted by nausea and vomiting
Outcome measures
| Measure |
Study Group
n=39 Participants
The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
Control Group
n=37 Participants
The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
|---|---|---|
|
Impact of Nausea and Vomiting on Quality of Life
|
18 percentage of participants
|
30 percentage of participants
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place