About this trial
Nausea and vomiting are common complications after anaesthesia, and anaesthetists routinely give medications to prevent them. Dexamethasone and ondansetron are the two most commonly used agents and have a long safety record. However, their effects on sleep, behaviour, and overall recovery are not well studied. Understanding these will guide future care. The aim of this study is to determine if dexamethasone or ondansetron given during an anaesthetic affect post-operative sleep, behaviour and recovery in children.
Patients enrolled in the study will be randomised to receive either dexamethasone or ondansetron during their procedure. This randomisation will be blinded to patients, their families and their treating anaesthetist. Information about the patient's pain, recovery and sleep will be collected over 7 days post-operatively using online surveys.
A subset of patients will also be asked to complete additional pre-operative non-invasive monitoring using an oximeter and an actigraph to measure their sleep quality before and after surgery. In addition to the postoperative surveys, these patients will be asked to wear the oximeter and actigraph for 3 nights before and immediatey after surgery. Patients who are admitted overnight postoperatively will also have additional transcutaneous carbon dioxide monitoring on the night of their surgery.
Eligibility criteria
Qualifiers
Children aged 2 - 15 years,
Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively
ASA I or III
Disqualifiers
Currently taking regular dexamethasone or ondansetron
Currently taking regular steroids, including inhaled corticosteroids
Anaesthetic plan to give dual PONV prophylaxis
Known hypersensitivity to the active substance or to any of the excipients listed
Trial design
Treatments tested in this trial
- Dexamethasone (IV)
- Ondansetron iv
Treatment groups
Sponsors and collaborators
Telethon Kids Institute
Lead sponsor
University of Sao Paulo General Hospital
Collaborator
Santa Casa de Misericórdia de Ribeirão Preto
Collaborator
Child and Adolescent Health Service - Perth
Collaborator