The incidence of post operative nausea and vomiting (PONV) is significantly higher in female patients than male patients and in patients having cholecystectomy, gynaecological surgery and laparoscopic surgery compared with general surgery. PONV is independently associated with a tripled incidence of admission after scheduled day surgery and has been the leading cause of unplanned admission in patients undergoing ambulatory gynaecological surgery. PONV is one of the most common reasons for patient dissatisfaction with anaesthesia.
The trial aims to determine whether chewing gum is non-inferior to ondansetron in achieving complete cessation of nausea, retching and vomiting within 2 h of administration, with no recurrence between cessation and 2 h after administration, and no rescue medication between administration and 2 h after administration (i.e. complete response) in female patients aged ≥12 years with nausea, retching and/or vomiting in the PACU after volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery.
Randomized, parallel-group, non-inferiority study conducted in a diverse network of adult and paediatric hospitals across Australia, New Zealand and Hong Kong affiliated with the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN).
Trial Length and Recruitment Aims at MBH
2 years, aiming at recruiting 20 patients. CHEWY currently has recruited 52 patients in its first year.