Official Title

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    ondansetron ...
  • Study Participants

    98
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).
Study Started
Apr 30
2009
Primary Completion
Jan 31
2010
Study Completion
Feb 28
2010
Results Posted
Aug 28
2012
Estimate
Last Update
Jan 31
2013
Estimate

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 names: Zofran

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.

Study Group Experimental

The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).

Control Group Placebo Comparator

The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).

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

Summary

Study Group

Control Group

All Events

Event Type Organ System Event Term

Incidence of Nausea

Percentage of participants with nausea

Control Group

54.0
percentage of participants

Study Group

46.0
percentage of participants

Impact of Nausea and Vomiting on Quality of Life

Percentage of participants whose quality of life was impacted by nausea and vomiting

Study Group

18.0
percentage of participants

Control Group

30.0
percentage of participants

Severity of Nausea

Percentage of participants reporting moderate or severe nausea in the first 24 hours

Study Group

23.0
percentage of participants

Control Group

32.0
percentage of participants

Total

76
Participants

Age Continuous

39
years (Mean)
Standard Deviation: 13

Sex: Female, Male

Overall Study

Study Group

Control Group