The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods. Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.
This study will evaluate whether jet-injected ketamine can provide adequate sedation to perform minimally invasive procedures in children with heightened procedural sensitivity in a pediatric sedation clinic environment. Minimally invasive procedures include, but are not limited to, blood draws, IV placement, and immunizations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
ketamine 2.5 mg/kg
University of Wisconsin - Madison
Madison, Wisconsin, United States
Feasibility of procedural success
Feasibility is measured by completion of the procedure using only the study drug. It is indicated by "yes" or "no".
Time frame: Up to 3 hours
Rate of procedural success
Percentage of participants who are able to complete the procedure using only the study intervention.
Time frame: Up to 3 hours
Time it takes to achieve target PSSS score
Time to PSSS score is measured from time of injection until target PSSS is achieved.
Time frame: Up to 20 minutes
Rate of adverse events
Reported as a percentage of total participants who experience an adverse event.
Time frame: Up to 3 hours
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