Phase 4
N=98
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
Nausea and Vomiting, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00878228 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Incidence of Nausea — 46; 54 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ondansetron (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Nausea |
46; 54 | — |
| SECONDARY Severity of Nausea |
23; 32 | — |
| SECONDARY Impact of Nausea and Vomiting on Quality of Life |
18; 30 | — |
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).
Eligibility Criteria
Inclusion Criteria
- All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- Willing to complete daily diary and be interviewed daily for three days after discharge
Exclusion Criteria
- Patients younger than 18 years old and older than 65
- Patients unable to undergo a spinal or epidural anesthetic
- Having nausea or vomiting within 24 hours of the surgery
- Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Hypersensitivity and/or allergy to ondansetron
- Intraoperative use of any volatile anesthetic
- Contraindication to a short course of NSAIDs (renal failure, intolerance)
- Allergy or intolerance to Vicodin
Data sourced from ClinicalTrials.gov (NCT00878228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.