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.
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
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
Parallel
Dexamethasone (IV)
DrugDexamethasone (0.2 mg/kg, maximum 8 mg) will be diluted to 2mL with normal saline and administered intravenously at the start of procedure.
Ondansetron iv
DrugOndansetron (0.15mg/kg, maximum 4mg) will be diluted to 2mL with normal saline and administered intravenously 15-30 minutes before the end of surgery
Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Parent-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Compare parent-reported sleep quality preoperatively and on postoperative days 2,3,5 and 7 between children who received dexamethasone and children who received ondansetron intraoperatively.
Sleep quality is measured on a 0 -10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Compare child-reported (if child is aged over 8 years) sleep quality on postoperative days 1, 2, and 7 between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
Child reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep
Compare parent reported postoperative recovery on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Postoperative recovery will be measured using the Pediatric Scale for Quality of Recovery (PedSQoR). The overall score will range from 20 to 100, higher scores indicate a better quality of recovery or a more complete recovery.
Compare parent reported postoperative behaviour on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group
Postoperative behaviour will be measured using the the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS). The scores range from 11 - 55. Higher scores indicate increased behavioural changes post-surgery,
Impact of sedative premedication on postoperative delirium
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Impact of sedative premedication on postoperative recovery
Postoperative recovery will be measured using the Pediatric Scale for Quality of Recovery (PedSQoR). The overall score will range from 20 to 100, higher scores indicate a better quality of recovery or a more complete recovery.
Impact of sedative premedication on postoperative sleep
sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
Impact of anaesthesia management on postoperative delirium
Emergence delirium will be assessed by the post-operative recovery nurse using the WATCHA Scale. The WATCHA Scale is scored from 0 (asleep) to 4 (thrashing around). Scores greater than or equal to 2 on this scale are indicative of emergence delirium.
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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
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