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July 1, 1992Clinical Pharmacology & Therapeutics

Ondansetron is effective in decreasing postoperative nausea and vomiting

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Key result

IV ondansetron increases complete response to ~58% versus placebo in women undergoing surgery.

  • P<0.001
  • n=50

Why the study?

The efficacy of ondansetron in preventing postoperative nausea and vomiting in surgical patients was studied to address the need for effective prophylaxis.

Does intravenous ondansetron prevent postoperative nausea and vomiting in female surgical patients?

Comparison

Two 8 mg doses of intravenous ondansetron vs two doses of placebo vehicle

Design

Randomized double-blind controlled trial

Follow-up

24 hours

Authors

MDMark DershwitzUniversity of Massachusetts Chan Medical SchoolCRCarl E. RosowHarvard UniversityPBP. M. Di BiaseResearch Triangle Park Foundation

Discussion

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Overview

Supports routine IV ondansetron use for PONV prophylaxis in women undergoing surgery; confirms efficacy versus placebo in this RCT.

Study Design

Type

RCT (n=50)

Blinding

Double-blind

Randomization

randomized

Structured PICO

Does intravenous ondansetron prevent postoperative nausea and vomiting in female surgical patients?

P
Population
50 women undergoing surgery with general anesthesia, evaluated for postoperative nausea and vomiting over 24 hours.
I
Intervention
Ondansetron 8 mg intravenous, two doses (first given just before general anesthesia induction, second 8 hours later)
C
Comparator
Placebo vehicle, two doses (first given just before general anesthesia induction, second 8 hours later)
O
Outcome
Number of emetic episodes and subjective nausea scores (0 to 10 scale) during the first 24 postoperative hourspatient reported

Main Result

Absolute Event Rate: 58% vs 4%

p-value: p=<0.001

Intravenous ondansetron is highly effective in preventing postoperative nausea and vomiting in female surgical patients.

Cite This Study

Dershwitz et al. (1992) conducted an RCT in Postoperative nausea and vomiting (n=50). Ondansetron vs. Placebo was evaluated on Complete responders (no emetic episodes and no rescue therapy) (p=<0.001). Intravenous ondansetron significantly increased the rate of complete responders (no emetic episodes or rescue therapy) compared to placebo (58% vs 4%, P<0.001) in women undergoing surgery.

synapsesocial.com/papers/6aacdc37defaaedc0aaab44chttps://doi.org/10.1038/clpt.1992.107
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Comparison of Ondansetron Versus Placebo to Prevent Postoperative Nausea and Vomiting in Women Undergoing Ambulatory Gynecologic Surgery1993 · 298 citations
  2. 2Single dose intravenous ondansetron in the prevention of postoperative nausea and vomiting1994 · 145 citations
  3. 3Ondansetron 4 mg for the Prevention of Nausea and Vomiting after Minor Laparoscopic Gynaecological Surgery1994 · 36 citations
  4. 4The effect of oral ondansetron in the prevention of postoperative nausea and vomiting after major gynaecological surgery performed under general anaesthesia1993 · 62 citations
  5. 5Intravenous Ondansetron for Postsurgical Opioid-Induced Nausea and Vomiting1997 · 28 citations