[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":94,"collaborators":96,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":25,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":128,"overallStatus":135,"whyStopped":25,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fkg (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.",[13],"Drug: Dexamethasone (IV)",{"label":15,"type":10,"description":16,"interventionNames":17},"Ondansetron Group","Ondansetron will be administered intravenously at 0.15 mg\u002Fkg (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.",[18],"Drug: Ondansetron iv",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dexamethasone (IV)","Dexamethasone (0.2 mg\u002Fkg, maximum 8 mg) will be diluted to 2mL with normal saline and administered intravenously at the start of procedure.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Ondansetron iv","Ondansetron (0.15mg\u002Fkg, maximum 4mg) will be diluted to 2mL with normal saline and administered intravenously 15-30 minutes before the end of surgery",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Britta S von Ungern-Sternberg, MD, PhD","CONTACT","+61864564806","britta.regli-vonungern@health.wa.gov.au",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Lliana Slevin, Bsc","+61 864564806","lliana.slevin@health.wa.gov.au",[41,66,84],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Perth Children's Hospital","Perth","Western Australia","6009","Australia","AU",{"type":49,"coordinates":50},"Point",[51,52],115.8614,-31.95224,{"lat":52,"lon":51},[55,56,57,60,62,64],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},{"name":58,"role":59,"phone":25,"phoneExt":25,"email":25},"David Sommerfield, MD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":25,"phoneExt":25,"email":25},"Mon Ohn, MD",{"name":63,"role":59,"phone":25,"phoneExt":25,"email":25},"Neil Hauser, MD",{"name":65,"role":59,"phone":25,"phoneExt":25,"email":25},"Nazim Khan, PHD",{"facility":67,"status":25,"city":68,"state":68,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Hospital das Clinicas","São Paulo","Brazil","BR",{"type":49,"coordinates":72},[73,74],-46.63611,-23.5475,{"lat":74,"lon":73},[77,81],{"name":78,"role":33,"phone":79,"phoneExt":25,"email":80},"Vinícius Quintão, MD, PhD","+55 11 2661 5795","vinicius.quintao@hc.fm.usp.br",{"name":82,"role":83,"phone":25,"phoneExt":25,"email":25},"Vinícius Quintão, MD PHD","PRINCIPAL_INVESTIGATOR",{"facility":85,"status":25,"city":68,"state":68,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Santa Casa de Misericórdia de Ribeirão Preto",{"type":49,"coordinates":87},[73,74],{"lat":74,"lon":73},[90,93],{"name":91,"role":33,"phone":79,"phoneExt":25,"email":92},"Ricardo Vieira Carlos, MD","ricardovieirac@gmail.com",{"name":91,"role":83,"phone":25,"phoneExt":25,"email":25},{"type":95,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[97,99,100],{"name":98,"class":6},"University of Sao Paulo General Hospital",{"name":85,"class":6},{"name":101,"class":102},"Child and Adolescent Health Service - Perth","OTHER_GOV","100652542","phase-4-sleep-quality---comparing-the-effect-of-ondansetron-or-dexamethasone-given-as-routine-prophylaxis-intraoperatively-to-prevent-post-operative-nausea-and-vomiting-scorpion-100652542",false,"NCT07777276","Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)","Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting","SCORPION","Inclusion Criteria:\n\n* Children aged 2 - 15 years,\n* Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively\n* ASA I or III\n\nExclusion Criteria:\n\n* Currently taking regular dexamethasone or ondansetron\n* Currently taking regular steroids, including inhaled corticosteroids\n* Anaesthetic plan to give dual PONV prophylaxis\n* Known hypersensitivity to the active substance or to any of the excipients listed\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in their care\n* Planned admissions to the Paediatric Intensive Care Unit (PICU)\n* Oncology patients\n* Severe developmental delay\n* ASA III or above\n* Significant cardiorespiratory conditions","ALL","2 Years","15 Years",{"count":115,"type":116},500,"ESTIMATED","INTERVENTIONAL",[119],"PHASE4","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.\n\nPatients 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.\n\nA 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.",[122,123,124,125,126,127],"Postoperative Sleep Quality","Postoperative Behaviour","Postoperative Recovery in Children","Postoperative Nausea and Vomiting (PONV)","Paediatric Surgery","Anaesthesia",[129,130,131,132,133,134],"paediatric","surgery","postoperative nausea and vomiting","paediatric anaesthesia","sleep quality","postoperative recovery","NOT_YET_RECRUITING","2026-08-18",{"date":138,"type":139},"2026-08-20","ACTUAL",{"date":141,"type":116},"2026-08-17",{"date":143,"type":116},"2029-08-17",{"name":5,"class":6},3]