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Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)
Sponsor: Telethon Kids Institute
Summary
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.
Official title: Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting
Key Details
Gender
All
Age Range
2 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-08-17
Completion Date
2029-08-17
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone (IV)
Dexamethasone (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
Ondansetron (0.15mg/kg, maximum 4mg) will be diluted to 2mL with normal saline and administered intravenously 15-30 minutes before the end of surgery
Locations (3)
Perth Children's Hospital
Perth, Western Australia, Australia
Hospital das Clinicas
São Paulo, São Paulo, Brazil
Santa Casa de Misericórdia de Ribeirão Preto
São Paulo, São Paulo, Brazil