[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511071":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":67,"collaborators":38,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":38,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":38,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":38,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Midazolam","EXPERIMENTAL","Dose\u002FConcentration: 5mg\u002Fml of 0.4mg\u002Fkg Midazolam (max dose 10mg). Adverse side effects include respiratory depression and hypotension. Intranasal Midazolam is standard of care for minimal procedures in pediatric ED.",[13],"Drug: Intranasal Midazolam",{"label":15,"type":10,"description":16,"interventionNames":17},"Intranasal Dexmedetomidine","Dose\u002FConcentration: 100mcg\u002Fml of 2mcg\u002Fkg Dexmedetomidine (max dose 100mcg). Adverse side effects include Hypotension and Bradycardia at high dosages. IV Dexmedetomidine is FDA approved and widely used in sedation. IN form isn't FDA approved; however, it has been approved to conduct research studies that have showed its efficacy in pre-operative settings, imaging-CT or MRI, dental procedures, and much more. Specifically, in a pediatric ED setting, Neville et al conducted a study comparing intranasal Dexmedetomidine and intranasal Midazolam prior to laceration repair in a pediatric emergency department and showed safe administration of Dexmedetomidine.",[18],"Drug: Intranasal Dexmedetomidine",{"label":20,"type":10,"description":21,"interventionNames":22},"Intranasal Ketamine","Dose\u002FConcentration: 100mg\u002Fml of 3mg\u002Fkg Ketamine (max dose 100mg). Adverse side effect include Laryngospasm. IV Ketamine is FDA approved and widely used in procedural sedation in pediatric EDs. IN form isn't FDA approved in pediatric population; however, it has also been approved to conduct research studies especially in combination with other medications. Gutherie et al conducted a study demonstrating intranasal Ketamine providing safe and successful anxiolysis in pediatric patients in an ED setting.",[23],"Drug: Intranasal Ketamine",[25,31,36],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Using a computer-generated randomization schedule by the research pharmacist, all 90 subjects will be divided into 3 even groups to receive either medication A (intranasal Midazolam), B (intranasal Dexmedetomidine), or C (intranasal Ketamine). Based on the randomization schedule, the pharmacist will dispense medication A, B, or C to the chronological number provided in the order. The total amount of the medication will be based on the patient's charted weight. Small volumes of less than 1ml per nostril are preferred for reliable absorption; therefore, the medication will be dispensed in a 1ml syringe and the barrel of the syringe will be covered by the pharmacist. All the syringes sent from the pharmacy will appear the same, regardless of the volume of the medication.",[9],[30],"Intranasal Versed",{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"See above",[15],[35],"Intranasal Precedex",{"type":26,"name":20,"description":32,"armGroupLabels":37,"otherNames":38},[20],null,[40],{"name":41,"affiliation":5,"role":42},"Ryan Mckee, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Gavely Toor, DO","CONTACT","405-271-2429","gavely-toor@ouhsc.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Oklahoma Health Sciences Center","RECRUITING","Oklahoma City","Oklahoma","73104","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-97.51643,35.46756,{"lat":62,"lon":61},[65],{"name":45,"role":46,"phone":38,"phoneExt":38,"email":66},"Gavely-Toor@ouhsc.edu",{"type":68,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100511071","phase-4-in-midazolam-vs-in-dexmedetomidine-vs-in-ketamine-during-minimal-procedures-in-pediatric-ed-100511071",false,"NCT05934669","IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED","Randomized Controlled Trial of Intranasal (IN) Midazolam vs IN Dexmedetomidine vs IN Ketamine Evaluating Length of Stay After Medication Administration and Anxiolysis During Minimal Procedures in Pediatric Population in Pediatric Emergency Department","Inclusion Criteria:\n\n* Age 1-5 years old\n* Presents to the ED for suture repair for lacerations less than or equal to 5cm in length\n* Parent(s)\u002FCaregiver(s) speak English\n\nExclusion Criteria:\n\n* Younger than 12 months of age or older than 5 years old\n* Suture repair needed for lacerations are greater than 5cm in length\n* Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives\n* Any abnormal vital signs for age, especially heart rate and blood pressure\n* History of Cardiac, respiratory, renal, or liver disease\n* Known electrolyte abnormalities\n* Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury\n* Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above\n* Known or anticipated difficult airway\n* Abnormal neurological exam\n* Parent(s)\u002FCaregiver(s) do not speak English",true,"ALL","1 Year","5 Years",{"count":81,"type":82},90,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.",[88,89,90],"Laceration of Skin","Anxiety","Discharge Time","2024-06-26",{"date":93,"type":94},"2024-06-28","ACTUAL",{"date":96,"type":94},"2023-11-14",{"date":98,"type":82},"2025-06",{"name":5,"class":6},1]