title: Chewing gum for the treatment of postoperative nausea and vomiting: a pilot randomized controlled trial.
abstract: BACKGROUND
  A novel treatment, chewing gum, may be non-inferior to ondansetron in inhibiting postoperative nausea and vomiting (PONV) in female patients after laparoscopic or breast surgery. In this pilot study, we tested the feasibility of a large randomized controlled trial.
  
  
  METHODS
  We randomized 94 female patients undergoing laparoscopic or breast surgery to ondansetron 4 mg i.v. or chewing gum if PONV was experienced in the postanaesthesia care unit (PACU). The primary outcome was full resolution of PONV, with non-inferiority defined as a difference between groups of <15% in a per protocol analysis. Secondary outcomes were PACU stay duration, anti-emetic rescue use, and acceptability of anti-emetic treatment. The feasibility of implementing the protocol in a larger trial was assessed.
  
  
  RESULTS
  Postoperative nausea and vomiting in the PACU occurred in 13 (28%) ondansetron patients and 15 (31%) chewing gum patients (P=0.75). Three chewing gum patients could not chew gum when they developed PONV. On a per protocol basis, full resolution of PONV occurred in five of 13 (39%) ondansetron vs nine of 12 (75%) chewing gum patients [risk difference 37% (6.3-67%), P=0.07]. There was no difference in secondary outcomes between groups. Recruitment was satisfactory, the protocol was acceptable to anaesthetists and nurses, and data collection was complete.
  
  
  CONCLUSIONS
  In this pilot trial, chewing gum was not inferior to ondansetron for treatment of PONV after general anaesthesia for laparoscopic or breast surgery in female patients. Our findings demonstrate the feasibility of a larger, multicentred randomized controlled trial to investigate this novel therapy.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12615001327572.
authors.affiliation: Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia jai.darvall@mh.org.au.|Royal Melbourne Hospital Clinical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.|Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: J N
authors.initials: JN
authors.lastname: Darvall
authors.affiliation: Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Handscombe
authors.affiliation: Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.|Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Victoria, Australia.|Department of Pharmacology and Therapeutics, University of Melbourne, Melbourne, Victoria, Australia.|Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: K
authors.initials: K
authors.lastname: Leslie
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use; D002638:Chewing Gum; D005260:Female; D006801:Humans; D008875:Middle Aged; D017294:Ondansetron / Q000627:therapeutic use; D010865:Pilot Projects; D020250:Postoperative Nausea and Vomiting / Q000628:therapy*
chemical_list: D000932:Antiemetics; D002638:Chewing Gum; D017294:Ondansetron
keywords: chewing gum; ondansetron; postanaesthesia nursing; postoperative nausea and vomiting