Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy (PDNV)
This study has been completed.
Sponsor:
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00878228
First received: April 7, 2009
Last updated: January 28, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea and Vomiting, Postoperative |
Drug: Ondansetron Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hospital for Special Surgery, New York:
Primary Outcome Measures:
- Incidence of Nausea [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]Percentage of participants with nausea
Secondary Outcome Measures:
- 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
| Enrollment: | 98 |
| Study Start Date: | April 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study Group
The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
|
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.
Other Name: Zofran
|
|
Placebo Comparator: Control Group
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878228
Locations
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
| Principal Investigator: | Jacques YaDeau, MD, PhD | Hosptial for Special Surgery |
More Information
Additional Information:
Publications:
| Responsible Party: | Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT00878228 History of Changes |
| Other Study ID Numbers: | 29015 |
| Study First Received: | April 7, 2009 |
| Results First Received: | July 23, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Antiemetics Ondansetron Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on June 17, 2013