[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506529":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":41,"responsibleParty":62,"collaborators":30,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":30,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":30,"overallStatus":44,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Arkansas Children's Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketorolac","ACTIVE_COMPARATOR","The group of patients will receive IV Ketorolac before placement of IUD under sedation.",[13],"Drug: Ketorolac",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The group of patients will receive placebo before placement of IUD under sedation.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will get IV ketorolac during IUD placement under sedation",[9],[26],"toradol",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Patients will get IV placebo during IUD placement under sedation",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Shahwar Yousuf, MD","CONTACT","501-364-1341","syousuf@uams.edu",{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},"Jill Gassaway","501-364-2862","GassawayJA@archildrens.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Arkansas Childrens Hospital","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-92.28959,34.74648,{"lat":54,"lon":53},[57,59],{"name":58,"role":34,"phone":35,"phoneExt":30,"email":36},"Shahwar Yousuf",{"name":60,"role":34,"phone":30,"phoneExt":30,"email":61},"Lee Crawley","crawleylj@archildrens.org",{"type":63,"investigatorFullName":58,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Principal Investigator, Pediatric Critical Care Fellow","100506529","phase-4-intravenous-ketorolac-administration-to-attenuate-post-procedural-pain-associated-with-intrauterine-device-placement-100506529",false,"NCT05875571","Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement","Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Patients requiring sedated IUD placement at Arkansas Children's Hospital\n\nExclusion Criteria:\n\n* Allergy to ketorolac or other NDSAID\n* Known history of renal impairment\n* History of GI bleeding of peptic ulcer disease",true,"FEMALE","13 Years","21 Years",{"count":77,"type":78},18,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement.\n\nPropofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement..\n\nThe current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.",[84,85,86,87],"IUD","Healthy Female","Contraception","IUD Insertion Complication","2024-07-30",{"date":90,"type":91},"2024-07-31","ACTUAL",{"date":93,"type":91},"2024-02-05",{"date":95,"type":78},"2025-06",{"name":5,"class":6},1]