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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-15
SponsorTelethon Kids Institute

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

500 Participants
are divided into 2 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