Article Text

Download PDFPDF

Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial
  1. Jai Darvall1,2,
  2. Britta Sylvia von Ungern-Sternberg3,4,
  3. Sabine Braat5,
  4. David Story2,
  5. Andrew Davidson6,7,
  6. Megan Allen1,2,
  7. An Tran-Duy8,
  8. Dana Middleton1,
  9. Kate Leslie1,2
  1. 1 Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia
  2. 2 Centre for Integrated Critical Care, University of Melbourne, Melbourne, Victoria, Australia
  3. 3 Department of Anaesthesia and Pain Management, Perth Children’s Hospital, Perth, Western Australia, Australia
  4. 4 Anaesthesia Unit, Medical School, University of Western Australia, Perth, Western Australia, Australia
  5. 5 Centre for Epidemiology and Biostatistics and Melbourne Clinical and Translational Science Platform, University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia
  6. 6 Department of Anaesthesia, Royal Children’s Hospital Melbourne, Melbourne, Victoria, Australia
  7. 7 Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
  8. 8 Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Jai Darvall; jai.darvall{at}mh.org.au

Abstract

Introduction Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year.

Methods and analysis This is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration.

Ethics and dissemination The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature.

Trial registration number ACTRN12618000429257; Pre-results.

  • chewing gum
  • ondansetron
  • postanaesthesia nursing
  • postoperative nausea and vomiting
  • recovery
  • perioperative complications/outcomes

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors JD: was involved in study design, protocol drafting and manuscript preparation. BSvU-S: was involved in study design, protocol drafting and manuscript proofing. SB: was involved in study design, protocol drafting and manuscript proofing. DS: was involved in study design, protocol drafting and manuscript proofing. AD: was involved in study design, protocol drafting and manuscript proofing. MA: was involved in study design, protocol drafting and manuscript proofing. AT-D: was involved in study design, protocol drafting and manuscript proofing. DM: was involved in study design, protocol drafting and manuscript preparation. KL: was involved in study design, protocol drafting and manuscript preparation.

  • Funding This work has been supported by a project grant from the Australian and New Zealand College of Anaesthetists, and the Victor Hurley Research grant from Melbourne Health. BSvU-S is partly funded by the Perth Children’s Hospital Foundation, the Stan Peron Charitable Trust and the Frank Callahan Estate.

  • Competing interests None declared.

  • Ethics approval Ethics approval for thisstudy has been granted by the Melbourne Health Human Research and EthicsCommittee (19 February 2018, HREC/18/MH/2).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.