[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593010":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Decongestant nasal spray (oxymetazoline hydrochloride 0.05%)","ACTIVE_COMPARATOR","Decongestant nasal spray, oxymetazoline (0.05%). Specific: 2.5mL of oxymetazoline 0.05% dispensed into amber brown 15ml bottles with pump and actuator attached. Children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart.",[13],"Drug: Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator : Placebo spray (control group)","PLACEBO_COMPARATOR","Matched Placebo spray. Specific: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% dispensed into amber brown 15ml bottles with pump and actuator attached. Dose: children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart.",[19],"Drug: PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))","Decongestant nasal spray containing active ingredient.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%","Control nasal spray containing no active ingredient.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Britta S. von Ungern-Sternberg, MD PHD","CONTACT","+618 6456 4806","britta.regli-vonungern@health.wa.gov.au",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Perth Children's Hospital","RECRUITING","Perth","We","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],115.8614,-31.95224,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Britta S von Ungern-Sternberg, MD PhD","+61864564805","Britta.Regli-VonUngern@health.wa.gov.au",{"name":57,"role":34,"phone":58,"phoneExt":26,"email":59},"Lliana B Slevin, BSC","+61426952977","lliana.slevin@thekids.org.au",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[63,66,69],{"name":64,"class":65},"Child and Adolescent Health Service - Perth","OTHER_GOV",{"name":67,"class":68},"Hospital das Clínicas de São Paulo - SP","UNKNOWN",{"name":70,"class":6},"Rigshospitalet, Denmark","100593010","phase-4-nasal-decongestant-to-reduce-perioperative-adverse-events-in-children-with-upper-respiratory-track-infections-having-anesthesia-100593010",false,"NCT07000877","Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.","Nasal Decongestant Administration to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having General Anesthesia - a Low Risk Intervention. (NARWHAL)","NARWHAL","Inclusion Criteria:\n\n* Children aged 1 to 8.99 years with a current or recent upper respiratory tract infection (\\\u003C2 weeks).\n* Undergoing interventions or surgery under general anesthesia (elective or urgent not emergency).\n\nExclusion Criteria:\n\n* Currently taking nasal decongestants (past 24 hours) or receiving co-phenylocaine or decongestion for surgery.\n* Surgery impacting the nasal airflow, e.g. adenoidectomy, cautery of inferior turbinates.\n* Airway management with an endotracheal tube, face mask or high flow nasal oxygen.\n* Known cardiovascular, respiratory or neurological disorders giving an ASA III or above.\n* Thyroid disease.\n* Diabetes.\n* Known hypersensitivity to the interventional products.\n* Department of Child Protection and Family Services involved in their care.\n* Planned admissions to the Paediatric Intensive Care Unit (PICU).","ALL","1 Year","8 Years",{"count":83,"type":84},200,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","The goal of this multicentre, double-blind, randomised controlled trial study is to learn if the use of a nasal spray to open the nasal passages and increase airflow before surgery can reduce the occurrence of perioperative respiratory adverse events in children with upper respiratory tract infection who are undergoing anesthesia.\n\nThe main questions it aims to answer are:\n\n* Does use of a nasal decongestant (Oxymetazoline 0.05%) reduce perioperative respiratory adverse events during emergence (when waking up from anesthesia) or in the post-anesthesia care unit in children.\n* Is it easy and acceptable to doctors, children and parents to use the nasal decongestant treatment? Researchers will compare the nasal decongestant to a placebo (a look-alike substance that contains no drug) to see if it works to reduce perioperative respiratory adverse effects.\n\nParticipants will:\n\n* Take a nasal decongestant or a placebo prior to surgery (just before anaesthesia is given)\n* Be monitored during and after surgery in the post-anaesthesia care unit for any perioperative respiratory adverse events.\n* Be asked about how acceptable they found the treatment.",[90,91],"Perioperative Respiratory Adverse Events","Anesthesia Outcomes",[93,94,95,96,97,98,99],"perioperative respiratory adverse events","nasal decongestant","upper respiratory tract infection","Children","surgery","pediatrics","anesthesia","2025-11-17",{"date":102,"type":103},"2025-11-19","ACTUAL",{"date":105,"type":103},"2025-06-25",{"date":107,"type":84},"2028-05-30",{"name":5,"class":6},1]