Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic. — Sleep quality will be assessed on day 1 post-surgery
  Parent-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.

Trial sites (3)

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