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Chewing Gum to Treat Postoperative Nausea and Emesis in Female Patients (CHEWY): Rationale and Design for a Multicentre Randomised Trial

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Chewing Gum to Treat Postoperative Nausea and Emesis in Female Patients (CHEWY): Rationale and Design for a Multicentre Randomised Trial Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2018-027505 on 12 June 2019. Downloaded from Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial Jai Darvall, 1,2 Britta Sylvia von Ungern-Sternberg,3,4 Sabine Braat,5 David Story,2 Andrew Davidson,6,7 Megan Allen,1,2 An Tran-Duy,8 Dana Middleton,1 Kate Leslie1,2 To cite: Darvall J, von ABSTRACT Strengths and limitations of this study Ungern-Sternberg BS, Braat S, Introduction Postoperative nausea, retching and vomiting et al. Chewing gum to treat (PONV) remains one of the most common side effects of ► This is the first large randomised trial designed to postoperative nausea and general anaesthesia, contributing significantly to patient emesis in female patients evaluate the impact of chewing gum on postopera- dissatisfaction, cost and complications. Chewing gum has (CHEWY): rationale and tive nausea and vomiting. potential as a novel, drug-free alternative treatment. We design for a multicentre ► The trial is designed as a multicentre, international aim to conduct a large, definitive randomised controlled randomised trial. BMJ Open study, enhancing external validity. 2019;9:e027505. doi:10.1136/ trial of the efficacy and safety of peppermint-flavoured ► The inclusion of health economic and treatment ac- chewing gum to treat PONV in the postanaesthesia care bmjopen-2018-027505 ceptability assessments is a strength of this trial. unit (PACU). If chewing gum is shown to be as effective ► Prepublication history for ► Limitations include the inability to blind patients and as ondansetron, this trial has the potential to significantly this paper is available online. postanaesthesia care unit nurses to group alloca- improve outcomes for tens of millions of surgical patients To view these files please visit tion, and restriction to patients aged ≥12 years (po- around the world each year. the journal online (http:// dx. doi. tentially reducing applicability to younger children). org/ 10. 1136/ bmjopen- 2018- Methods and analysis This is a prospective, multicentre, 027505). randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based Received 25 October 2018 general anaesthesia for breast or laparoscopic surgery will after scheduled day surgery compared with Revised 21 March 2019 be randomised. Patients experiencing nausea, retching or no PONV, and has been the leading cause of http://bmjopen.bmj.com/ Accepted 2 May 2019 vomiting in PACU will be randomised to 15 min of chewing unplanned admission in patients undergoing gum or 4 mg intravenous ondansetron. The primary ambulatory gynaecological surgery.7 8 In chil- outcome (complete response) is cessation of PONV within dren, PONV accounts for 25% of admissions 2 hours of administration, with no recurrence nor rescue following scheduled day surgery.9 PONV leads medication requirement for 2 hours after administration. to increased costs of treatment and hospital Ethics and dissemination The Chewy Trial has been approved by the Human Research Ethics Committees at all care, increased length of stay in the postan- sites. Dissemination will be via international and national aesthesia care unit (PACU) and logistical anaesthesia conferences, and publication in the peer- difficulties for hospitals, patients and their on September 25, 2021 by guest. Protected copyright. 10 reviewed literature. families. PONV remains one of the most Trial registration number ACTRN12618000429257; Pre- common reasons for patient dissatisfaction results. with anaesthesia,11 and patients are willing to pay up to US$100 to avoid PONV.12 Numerous guidelines on the prophylaxis INTRODUCTION and treatment of PONV have been published. More than 300 million patients have surgery The Consensus Guidelines published by each year worldwide, with the greatest growth the Society for Ambulatory Anesthesiology © Author(s) (or their in recent years in low-income nations.1Post- provide the most authoritative summary of employer(s)) 2019. Re-use operative nausea, retching and vomiting the evidence.3 Despite their wide and long- permitted under CC BY-NC. No commercial re-use. See rights (PONV) affects up to 80% of untreated standing promulgation, and a wealth of and permissions. Published by patients after general anaesthesia, females PONV literature, evidence suggests poor BMJ. disproportionately more than males, and compliance with the Guidelines, especially For numbered affiliations see contributes significantly to patient discomfort, in low-income nations.6 10 13 In one study of end of article. costs of care and potentially life-threatening over 23 000 anaesthetics, only 30% of high Correspondence to complications such as aspiration and wound risk patients received the recommended 2–6 14 Dr Jai Darvall; dehiscence. PONV is independently asso- antiemetic prophylaxis. Therefore, PONV jai. darvall@ mh. org. au ciated with a tripled incidence of admission remains a significant problem that requires Darvall J, et al. BMJ Open 2019;9:e027505. doi:10.1136/bmjopen-2018-027505 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-027505 on 12 June 2019. Downloaded from treatment. When PONV occurs, with or without prophy- nurses, and data collection was complete. Twenty-eight of laxis, the Guidelines recommend treatment with a range the 94 patients (30%) developed nausea, retching and/ of first-line drugs such as 5-HT3 receptor antagonists (eg, or vomiting in the PACU (13 randomised to ondanse- ondansetron) and butyrophenones (eg, droperidol). tron; 15 randomised to chewing gum, of whom two were These drugs have side effects, for example prolonged QT insufficiently awake and one refused to chew gum). Using interval, headache, elevated liver enzymes and constipa- a hypothesised difference for equivalence of 15%, on a tion.3 Additionally, the combination of large numbers per-protocol basis (preferred methodology for testing a of patients treated and treatment failures can be costly, non-inferiority hypothesis23), complete response of the particularly in low-income nations in which surgical first episode of nausea, retching and/or vomiting without volumes are rapidly rising (115% increase in surgery requirement for rescue medication occurred in 9 of 12 rate between 2004 and 2012 for countries with per capita (75%) of chewing gum patients versus 5 of 13 (38.5%) health expenditure <US$400 per annum1). The cost of of ondansetron (risk difference 37%, 90% CI 6% to 67%, antiemetic drugs may be paradoxically higher in these p=0.07). The intention-to-treat findings were consistent regions, for example, while ondansetron costs US$0.15 with the per-protocol results. in Australia, it costs US$1.11 in the Sudan, about 2% of We aim to demonstrate the non-inferiority of this the total annual per capita health spend in that nation.15 simple and inexpensive treatment compared with ondan- To minimise both harm and cost, there is emerging setron for the common and distressing problem of PONV interest in drug-free alternative treatments for PONV. in a multicentre, randomised controlled trial. This study Acupuncture at the P6 point on the inner forearm16 and has the potential to introduce a novel drug-free treatment ginger17 have proved efficacious in preventing PONV for a common complication of anaesthesia and surgery, compared with placebo, and acustimulation has been without the side effects and cost associated with conven- reported as equivalent to ondansetron for treatment.18 tional drug treatment. As such, it has potential to signifi- These modalities have not seen widespread uptake, cantly improve health outcomes and save money for however, due to clinician unfamiliarity, and training and millions of patients and health services in high-income, equipment requirements. A simple drug- and equip- middle-income and low-income nations worldwide. ment-free treatment—chewing gum—has been found to be efficacious for the related problem of postoperative Study hypotheses paralytic ileus following gastrointestinal surgery. Hypothe- Our primary hypothesis is that chewing gum is non-infe- sised mechanisms of its effect include ‘sham feeding’, with rior to ondansetron in achieving complete cessation of increased gastrointestinal activity mediated via cephal- nausea, retching and vomiting within 2 hours of admin- ic-vagal stimulation from chewing. A 2015 meta-analysis istration, with no recurrence between cessation and 2 hours after administration, and no rescue medication including 9072 patients across 81 randomised controlled http://bmjopen.bmj.com/ trials demonstrated evidence for reduced postoperative between administration and 2 hours after administration ileus and earlier hospital discharge.19 We hypothesise that (ie, complete response), in female patients aged ≥12 mechanisms underpinning the efficacy of chewing gum years with nausea, retching and/or vomiting in the PACU in the resolution of postoperative ileus may have a role in after volatile anaesthetic-based general anaesthesia for the treatment of PONV. breast or laparoscopic surgery. Our secondary hypotheses are that chewing gum is superior to ondansetron with Feasibility respect to: (1) complete response (as defined above), if chewing gum is found to be non-inferior; (2) accept- We assessed the feasibility of chewing gum in an initial on September 25, 2021 by guest. Protected copyright. prospective cohort study, which enrolled 41 female ability of randomised treatment to patients and PACU
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