TerminatedPhase 4ketamine
Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
Sponsored by Brooke Army Medical Center
NCT ID
NCT03043430
Target Enrollment
10 participants
Start Date
2016-05
Est. Completion
2023-04
About This Study
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
Conditions Studied
Interventions
- •Ketamine 100 MG/ML
- •Midazolam 5 MG/ML
Eligibility
Age:2 Years - 12 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Patients age 2 to 12 years who present to the ED * Requiring intravenous access * Requiring laceration repairs * Requiring incision and drainage of abscesses * Requiring digital nerve blocks * Requiring radiological imaging * Requiring bladder catheterization * Requiring foreign body removal. Exclusion Criteria: * Vital sign abnormalities greater than 20% deviation from age-normalized ranges * Altered mental status/delirium or intoxication * Patient or patient's parent/guardian are unwilling to participate or provide informed consent * Any allergy to ketamine or midazolam * Patient is female with history of menarche * Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis * Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias * Presence of intracranial mass or vascular lesion. * Presence of a history of psychosis or hallucinations * Weight greater than 100kg * History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months * Non-English speaking/reading parent/guardian and/or patients * Patient is acutely psychotic * Provider feels that patient currently or likely will require chemical and/or physical restraints * History of prolonged QT-interval * Nasal trauma * Epistaxis
Study Locations (1)
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States