Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07777276
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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