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- Jai N Darvall, De SilvaAnurika PAPCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia; and Methods and Implementation Support for Clinical and Health (MISCH) research Hub, Faculty of , Britta von Ungern-Sternberg, David A Story, Andrew J Davidson, Megan L Allen, An Tran-Duy, Cindy Schultz-Ferguson, Vi Ha, Sabine Braat, Kate Leslie, and CHEWY Trial Group and the ANZCA Clinical Trials Network.
- Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia; and Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia. Email: jai.darvall@mh.org.au.
- Anesthesiology. 2024 Oct 30.
BackgroundPostoperative nausea and vomiting (PONV) is common after general anesthesia, with consequences for patient outcomes, satisfaction with care and healthcare costs. Our aim was to compare a new treatment, chewing gum, with a widely-used intravenous agent, ondansetron, to treat PONV in female patients in the post anesthesia care unit (PACU).MethodsWe conducted a multicenter, randomized, controlled non-inferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged ≥12 years undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized anti-emetic prophylaxis was administered. Patients who developed PONV in the PACU were randomized to either 15 min of chewing gum or 4 mg of intravenous ondansetron. The primary outcome was cessation of nausea, retching or vomiting, with no recurrence nor rescue medication for 2 h after administration of the randomized intervention (i.e., complete response).ResultsOf 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% confidence interval (CI)] -17.3 [-30.4 to -4.3] %), not reaching our prespecified non-inferiority limit. Time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI] 0.53 [0.34, 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI] 14.07 [1.65, 26.49]).ConclusionsChewing gum cannot be recommended as an alternative to ondansetron for treatment of PONV in female patients administered antiemetic prophylaxis.Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.
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