A multicentre, randomised, non-inferiority trial of chewing gum versus ondansetron to treat postoperative nausea and vomiting in female patients after breast or laparoscopic surgery (The Chewy Trial)
Phase 4
- Conditions
- Postoperative nausea and vomitingAnaesthesiology - AnaestheticsSurgery - Other surgery
- Registration Number
- ACTRN12618000429257
- Lead Sponsor
- Melbourne Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Female
- Target Recruitment
- 212
Inclusion Criteria
Female patients aged 12 years or older, weight 30 kg or more, preoperative Apfel score 2-4, presenting for breast or laparoscopic surgery under volatile-based, general anaesthesia.
Exclusion Criteria
Patients having propofol-maintained general anaesthesia or inhalational induction without propofol co-induction, a contraindication to chewing gum, or any protocolised anti-emetic drug (prophylaxis, intervention or rescue), treatment with any of the study anti-emetic medications within 8 hours of induction of anaesthesia or planned post operative ventilation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with complete cessation of nausea, retching and vomiting within 2 hours of administration (composite outcome), with no recurrence between cessation and 2 hours after administration, and no rescue medication between administration and 2 hours after administration (i.e. complete response). (Investigator direct observation for vomiting/nausea and direct interview for nausea using verbal descriptive scale)[ Within 2 hours of administration of randomised intervention (nausea assessed every 15 minutes, with the primary timepoint at 2 hours).]
- Secondary Outcome Measures
Name Time Method