Status:
TERMINATED
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Trauma
Fractures, Closed
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Detailed Description
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-opera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03781817
Start Date
September 9 2019
End Date
April 30 2022
Last Update
April 20 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233