[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473739":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":68,"collaborators":18,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":18,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":18,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"participants receiving oraverse injection after local anaesthetic administration","EXPERIMENTAL","participants receive phentolamine mesylate (Oraverse) injection after the completion of their dental procedures with ratio 1:1 to LA in children weighed 30 kg and more while in children less than 30 kg only half of the amount of the cartridge is administrated.",[13],"Drug: OraVerse",{"label":15,"type":16,"description":17,"interventionNames":18},"participants with no drug after local anaesthetic administration","NO_INTERVENTION","participants don't receive any reversal agent or placebo after the completion of their dental procedures.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","OraVerse","Phentolamine mesylate is a vaso-dilator that was used for treating dermal necrosis and severe hypertension cases since 1952. It is alpha-adrenergic antagonist. Oraverse is supplied in a dose equal to the amount of LA taken in adults and children with weights more than 30 kg. While in children less than 30 kg, it is advised to use only half carpule according the manufacturer's instructions.",[9],[26],"phentolamine mesylate",[28],{"name":29,"affiliation":30,"role":31},"mahmoud hamdy, professor","main supervisor","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"alaa saad abourawash","CONTACT","01144942076","alaa.saad@dentistry.cu.edu.eg",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"passant nagy","01280557107","passant.nagi@dentistry.cu.edu.eg",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Cairo","El Manial","11562","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.24967,30.06263,{"lat":54,"lon":53},[57,60,63,66],{"name":58,"role":35,"phone":59,"phoneExt":18,"email":37},"Alaa Saad, bachelor degree of science","00201144942076",{"name":61,"role":35,"phone":62,"phoneExt":18,"email":41},"Passant Nagi","00201280557107",{"name":64,"role":65,"phone":18,"phoneExt":18,"email":18},"Alaa Saad, Bachelor degree of science","PRINCIPAL_INVESTIGATOR",{"name":61,"role":67,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":65,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Alaa Saad Abourawash Tolba","doctor","100473739","phase-3-effectiveness-of-phentolamine-mesylate-as-a-reversing-agent-for-local-anesthesia-in-children-100473739",false,"NCT05448807","Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children","A Randomized Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Decreasing Self- Inflicted Soft Tissue Trauma Following Local Anaesthesia Injection for Dental Procedure in Children: Randomized Clinical Trial","Inclusion Criteria:\n\nChildren aged 5-7 years.\n\n* Patients in need of dental procedures requiring local anaesthesia.\n* Healthy Children without any systemic or mental disorders.\n* Normal lip sensation before administration of LA.\n* Normal paediatric functional assessment battery (pFAB) for smiling, speaking and drinking and absence of drooling.\n\nExclusion Criteria:\n\n* Children seeking dental treatment that does not necessitate local anaesthesia.\n* Children who didn't achieve profound numbness requiring additional anaesthesia.\n* Children who lack the ability to distinct the anaesthetised numb side from the non-anaesthetised one.\n* Children who are not willing to participate in the study.",true,"ALL","5 Years","7 Years",{"count":83,"type":84},100,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth",[90],"Soft Tissue Injuries",[92],"lip biting hematoma","2025-07-06",{"date":95,"type":96},"2025-07-10","ACTUAL",{"date":98,"type":96},"2025-07-05",{"date":100,"type":84},"2026-06",{"name":5,"class":6},1]