None listed
Conditions
Brief summary
The aim of this pilot trial is to determine the efficacy and safety of chewing gum compared with ondansetron for the treatment of postoperative nausea or vomiting (PONV). PONV is a significant complication of general anaesthesia. In addition to patient dissatisfaction resulting from PONV, the cost burdens of anti-emetic therapy and delayed discharge from the PACU are considerable. Chewing gum in the postoperative period has been well established in the treatment of ileus resulting from gastrointestinal surgery, but its efficacy as a treatment for PONV has to date not been assessed. A prospective cohort study conducted by this research team on the use of chewing gum in the PACU confirmed its acceptability to patients and staff. We now propose to determine the non-inferiority of chewing gum to ondansetron for PONV. The results of this pilot study will guide a future large randomised controlled trial assessing the efficacy of this comparative simple therapy, of negligible cost. This study thus has the potential to significantly improve patient and health service outcomes. The aims of the pilot study 1. Refine and test the trial protocol for a large multicentre study 2. Assess acceptability of the trial protocol to our patients and anaesthetic/nursing staff, as a high recruitment and participation rate will be required for a viable definitive study. 3. Confirm the high rates of PONV despite prophylaxis seen in our prior trial, to inform sample size estimates for a definitive trial. 4. Assess the proportion of patients meeting criteria for chewing gum in the PACU, to guide the external validity of this trial. 5. Assess the event rates using the protocol developed Hypothesis to be tested Chewing gum in the immediate postoperative period is efficacious and safe compared to ondansetron in the treatment of PONV.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Female patients aged 18 years and over American Society of Anesthesiologists’ (ASA) physical status 1-3 Laparoscopic or breast surgery (wide local excision/mastectomy)
Exclusion criteria
Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability Significant cardiorespiratory impairment (i.e. ASA 4 patients) Impaired pharyngeal/oesophageal function (e.g. bulbar palsy, achalasia) Phenylketonuria (contraindication to sweetener aspartame in chewing gum) Contraindication to dexamethasone (e.g. severe uncontrolled diabetes mellitus, uncontrolled infection) Contraindication to droperidol (e.g. prolonged QT syndrome) Contraindication to ondansetron Full upper or lower denture (not feasible to chew gum)