[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333721":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":60,"collaborators":36,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":36,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Children's Healthcare of Atlanta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Participants will be randomized to either Control Group or Gabapentin Group",[13],"Drug: Gabapentin",{"label":15,"type":16,"description":11,"interventionNames":17},"Gabapentin Group","ACTIVE_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Gabapentin","This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T\u002FAs. Patients will be receiving either one gabapentin dose (15mg\u002Fkg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.",[15,9],[25],"Neurontin",[27],{"name":28,"affiliation":29,"role":30},"Christina Calamaro, PhD, CPNP-PC","Institutional Review Board","STUDY_CHAIR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Beena Desai","CONTACT","404-785-2269",null,"beena.desai@choa.org",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Margaret A Gettis, DNP,CPNP-PC","404-785-8622","margaret.gettis@choa.org",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Atlanta","Georgia","30329","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-84.38798,33.749,{"lat":54,"lon":53},[57,58],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":59,"role":34,"phone":40,"phoneExt":36,"email":41},"Margaret A. Gettis, DNP,CPNP-PC",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Margaret Gettis","Nurse Scientist","100333721","phase-4-gabapentin-premedication-to-reduce-postoperative-pain-for-pediatric-tonsillectomy-100333721",false,"NCT03625011","Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy","Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy\u002FAdenoidectomy: Randomized Control Trial","Inclusion Criteria:\n\n* participants age 3-18 years\n* ASA class 1 or 2\n* elective Tonsillectomy\u002FAdenoidectomy\n* outpatient setting.\n\nExclusion Criteria:\n\n* BMI \\>40kg\u002Fm2\n* history of renal insufficiency, chronic pain\n* allergy to gabapentin\n* history of developmental delay",true,"ALL","3 Years","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg\u002Fkg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg\u002Fkg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg\u002Fkg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.",[83,84],"Tonsillitis","Tonsillectomy",[86,87],"Pain Relief","Non-Narcotic Pain relief","2019-07-23",{"date":90,"type":91},"2019-07-24","ACTUAL",{"date":93,"type":91},"2018-07-31",{"date":95,"type":77},"2019-12-31",{"name":5,"class":6},1]