[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657084":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":40,"interventions":65,"overallOfficials":30,"centralContacts":30,"locations":71,"responsibleParty":103,"collaborators":30,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":30,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":30,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":30,"overallStatus":74,"whyStopped":30,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"British University In Egypt","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Visual Analog Scale (VAS)","Pain Intensity assessed by visual analogue scale","Immediately after intervention",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Phase 1 outcome","The preferred sweet tasting solution based on number of patients","After intervention",{"measure":19,"description":20,"timeFrame":21},"Heart Rate","Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection","Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection",{"measure":23,"description":24,"timeFrame":25},"Sound, eye and motor scale (SEM) scale","Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain.","During needle injection",{"measure":27,"description":28,"timeFrame":29},"Oxygen saturation","Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection.","Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":36,"maskingDescription":30,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","OUTCOMES_ASSESSOR",[41,46,49,52,55,58,61],{"label":42,"type":43,"description":30,"interventionNames":44},"Precooling group","EXPERIMENTAL",[45],"Behavioral: Dental anesthesia",{"label":47,"type":43,"description":30,"interventionNames":48},"Precooling + topical anaesthesia group",[45],{"label":50,"type":43,"description":30,"interventionNames":51},"Precooling + sweet tasting solution group",[45],{"label":53,"type":43,"description":30,"interventionNames":54},"Precooling + sweet tasting solution + topical anaesthesia",[45],{"label":56,"type":43,"description":30,"interventionNames":57},"Sweet tasting solution group",[45],{"label":59,"type":43,"description":30,"interventionNames":60},"Sweet tasting solution + topical anaesthesia group",[45],{"label":62,"type":63,"description":30,"interventionNames":64},"Topical anaesthesia group","ACTIVE_COMPARATOR",[45],[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":30},"BEHAVIORAL","Dental anesthesia","The intervention consists of pre-cooling and\u002For a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection.",[53,50,47,42,59,56,62],[72],{"facility":73,"status":74,"city":75,"state":76,"zip":30,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Faculty of Dentistry, British University in Egypt","RECRUITING","Cairo","El Sherouk","Egypt","EG",{"type":80,"coordinates":81},"Point",[82,83],31.24967,30.06263,{"lat":83,"lon":82},[86,91,95,98,101],{"name":87,"role":88,"phone":89,"phoneExt":30,"email":90},"Nada M Farouk, post graduate student","CONTACT","+21020668262","pg.nada92243007@bue.edu.eg",{"name":92,"role":88,"phone":93,"phoneExt":30,"email":94},"Ola A Abd El-geleel, Associate Professor","+21006086830","ola@dent.asu.edu.eg",{"name":96,"role":97,"phone":30,"phoneExt":30,"email":30},"Noha S Kabil, professor","SUB_INVESTIGATOR",{"name":99,"role":100,"phone":30,"phoneExt":30,"email":30},"Nada M Farouk, bachelors degree","PRINCIPAL_INVESTIGATOR",{"name":102,"role":97,"phone":30,"phoneExt":30,"email":30},"Ola A Abd El-Geleel, associate professor",{"type":100,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Nada Mohammed Farouk","Principal investigator","100657084","efficacy-of-pre-cooling-and-sweet-tasting-solution-on-pain-related-to-local-anesthesia-injection-in-children-100657084",false,"NCT07835191","Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children","Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial","Inclusion Criteria:\n\n1. Age group 7-11 years\n2. Patients requiring infiltration anesthesia to fulfill dental therapeutic needs\n3. Frankl behavior scale 3 and 4\n\nExclusion Criteria:\n\n1. Failure to provide assent or consent\n2. Allergy from local anesthetic solution\n3. Systemic diseases such as diabetes that could affect pain perception\n4. History of abscess or fistula at site of injection","ALL","7 Years","11 Years",{"count":117,"type":118},224,"ESTIMATED","INTERVENTIONAL",[121],"NA","The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children.\n\nIt has two phases:\n\nPhase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey.\n\nPhase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations.\n\nThe primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.",[124,125,126,127],"Dental Anesthesia","Sweet Taste Perception","Pain and Anxiety","Behavioral Management","2026-09-16",{"date":130,"type":131},"2026-09-22","ACTUAL",{"date":133,"type":131},"2025-10-06",{"date":135,"type":118},"2027-04",{"name":5,"class":6},1]