TerminatedPhase 4ketamine
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Sponsored by University of Alabama at Birmingham
NCT ID
NCT03781817
Target Enrollment
40 participants
Start Date
2019-09-09
Est. Completion
2022-04-30
About This Study
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Conditions Studied
Interventions
- •Intravenous Ketamine
- •Intranasal Ketamine
Eligibility
Age:1 Year - 18 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Children 1-18 years of age. * American Society of Anesthesiologists (ASA) I or II * Non-operative fracture requiring reduction * Body weight less than or equal to 25 kg as measured by standard weighing scale Exclusion Criteria: * ASA classification III or above * Age less than 1 year * History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder * Prior allergy to ketamine * Unavailable parent or guardian to provide consent * Non-English speaking
Study Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States