[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"laceration-of-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:laceration-of-skin":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100586043","phase-3-lidocaine-versus-diphenhydramine-to-achieve-local-anesthesia-for-laceration-repairs-100586043",false,"NCT06910241","Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs","Inclusion Criteria:\n\n* Lacerations requiring one layer of sutures\n* Lacerations appropriate for repair by emergency physicians\n\nExclusion Criteria:\n\n* Active bleeding from laceration\n* Complex lacerations requiring multiple layers\n* Lacerations to be repaired by a specialist service\n* Patients with allergies to either diphenhydramine or lidocaine\n* Laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic",true,"ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.",[26],"Laceration of Skin","RECRUITING","2026-01-06",{"date":30,"type":31},"2026-01-07","ACTUAL",{"date":33,"type":31},"2025-09-03",{"date":35,"type":20},"2028-06-30",{"name":37,"class":38},"Florida Atlantic University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100468723","phase-3-anxiolysis-for-laceration-repair-in-children-100468723","NCT05383495","Anxiolysis for Laceration Repair in Children","Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial","ALICE","Inclusion Criteria:\n\ni) Age 2-12.99 years \\[highest incidence of laceration repair\\] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designate (trainee) iv) Child or caregiver desires anxiolysis for laceration repair \\[justification: incorporates family preferences based on their prior experiences or beliefs about child's response\\] vii) Local anesthesia planned to involve topical anesthetic (LET), infiltrated lidocaine, ring, or thenar block\n\nExclusion Criteria:\n\ni) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist \\\u003C 24 hours prior to interventions (may compound sedative effect and increase the SAE risk). 24-hours encompasses the duration of sedation of most agents.\n\nii) Hypersensitivity to any intervention iii) Occlusion of \\> 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug absorption) iv) Hemodynamic abnormalities: bradycardia or hypotension \\\u003C 2 SD of age-related normal value v) IND contraindications: Pre-existing renal insufficiency, uncorrected mineralocorticoid deficiency, pulmonary hypertension, uncorrected cyanotic heart disease, cardiac conduction disorder, pulmonary hypertension, pulmonary edema, vitamin B12 or folate disorder, phenylketonuria, or psychosis vi) Sedation contraindications: Impaired level of consciousness or respiratory instability vii) N2O contraindications: Conditions associated with potential accumulation of gas within body spaces viii) Suspected or confirmed pregnancy (as reported by patient) ix) Inability to vocalize pain due to motor deficits (unable to apply the OSBD-R) x) Caregiver unable to complete study tasks due to insufficient comprehension of either English or French in the absence of a native language interpreter xi) Weight \\>= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or II (controlled mild to moderate disease) xii) No concomitant fracture or dislocation requiring orthopedic manipulation","2 Years","12 Years",{"count":51,"type":20},300,[23],"This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).",[26,55],"Distress, Emotional","2025-04-29",{"date":58,"type":31},"2025-04-30",{"date":60,"type":31},"2023-12-19",{"date":62,"type":20},"2026-12-31",{"name":64,"class":38},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":15,"sex":16,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":39},"100511071","phase-4-in-midazolam-vs-in-dexmedetomidine-vs-in-ketamine-during-minimal-procedures-in-pediatric-ed-100511071","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","1 Year","5 Years",{"count":75,"type":20},90,[77],"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.",[26,80,81],"Anxiety","Discharge Time","2024-06-26",{"date":84,"type":31},"2024-06-28",{"date":86,"type":31},"2023-11-14",{"date":88,"type":20},"2025-06",{"name":90,"class":38},"University of Oklahoma"]