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

NCT07777276 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: RGS0000008604
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Postoperative Sleep Quality; Postoperative Behaviour; Postoperative Recovery in Children; Postoperative Nausea and Vomiting (PONV); Paediatric Surgery; Anaesthesia

Keywords

paediatric; surgery; postoperative nausea and vomiting; paediatric anaesthesia; sleep quality; postoperative recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  Sleep quality will be assessed on day 1 post-surgery

Secondary Outcomes (11)

• 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.

  Parent-reported preoperative sleep quality will be collected on the day of surgery and postoperatively on days 2,3,5 and 7.

• 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 measure don days 1, 2, and 7 postoperatively

• 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 postoperative days 1, 2, 3, 5, and 7

• 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 on postoperative days 1, 2, 3, 5, and 7

• Compare parent reported average and maximum pain score on postoperative days 1, 2, 3, 5, and 7 or until the child has returned to normal function between children in the dexamethasone group and children in the ondasetron group

  postoperative pain will be measured on days 1, 2, 3, 5 and 7 or until the child returns to normal function.

Other Outcomes (22)

• Impact of sedative premedication on postoperative delirium

  Delirium will be assessed from PACU arrival until PACU discharge criteria met

• Impact of sedative premedication on postoperative recovery

  Postoperative days 1,2,3,5, and 7

• Impact of sedative premedication on postoperative sleep

  postoperative days 1,2,3,5, and 7

Study Arms (2)

Dexamethasone Group

ACTIVE COMPARATOR

Dexamethasone will be sourced from the hospital pharmacy as standard registered medications. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. Dexamethasone will be administered intravenously at 0.2 mg/kg (maximum 8 mg) at the start of procedure.The patient-specific dose of the investigational product will be diluted to 2ml with normal saline to ensure blinding of the anaesthetist in charge of the patient. The trial will mimic this institutional standard practice by providing two syringes to every treating anaesthetist. The first syringe will contain the patient's dose of dexamethasone diluted to 2mL, the second syringe will contain 2mL of normal saline.

Drug: Dexamethasone (IV)

Ondansetron Group

ACTIVE COMPARATOR

Ondansetron will be administered intravenously at 0.15 mg/kg (maximum 4 mg) 15-30 min before the end of surgery. The dose will be diluted to 2ml with normal saline to ensure blinding by the anaesthetist. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. The first syringe will contain 2mL of normal saline, the second syringe will contain the patient's dose of ondansetron diluted to 2mL.

Drug: Ondansetron iv

Interventions

Dexamethasone (IV) DRUG

Dexamethasone (0.2 mg/kg, maximum 8 mg) will be diluted to 2mL with normal saline and administered intravenously at the start of procedure.

Dexamethasone Group

Ondansetron iv DRUG

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

Ondansetron Group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Language barriers impeding data collection
• Department for Child Protection and Family Support is involved in their care
• Planned admissions to the Paediatric Intensive Care Unit (PICU)
• Oncology patients
• Severe developmental delay
• ASA III or above
• Significant cardiorespiratory conditions

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Santa Casa de Misericórdia de Ribeirão Preto: collaborator
• University of Sao Paulo General Hospital: collaborator
• Child and Adolescent Health Service - Perth: collaborator

Study Sites (3)

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

Location

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Location

Santa Casa de Misericórdia de Ribeirão Preto

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Sleep Initiation and Maintenance Disorders

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Britta S von Ungern-Sternberg, MD, PhD

CONTACT

+61864564806; britta.regli-vonungern@health.wa.gov.au

Lliana Slevin, Bsc

CONTACT

+61 864564806; lliana.slevin@health.wa.gov.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a mulitcentre double-blinded, randomised, controlled pilot trial

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 20, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): August 17, 2029
• Study Completion (Estimated): August 17, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2); AU (1)