TerminatedEarly Phase 1ketamine
Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
Sponsored by University of Arizona
NCT ID
NCT03067974
Target Enrollment
10 participants
Start Date
2017-09-21
Est. Completion
2019-01-22
About This Study
The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
Conditions Studied
Interventions
- •Ketamine Hcl 100Mg/Ml Inj
Eligibility
Age:2 Years - 7 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus * Body weight of 20kg or less (actual, estimated, or measured) * NPO for four hours or more * Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure. Exclusion Criteria: * Discretion of parents * Discretion of provider * Body weight greater than 20kg (actual, estimated, or measured) * Starting Aldrete score \<9/10 * Known or suspected psychosis * Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure * Significant elevation in blood pressure * Known hypersensitivity to ketamine * Non-English or Spanish speaking
Study Locations (1)
Banner Univsersity Medical Center Tucson
Tucson, Arizona, United States