Status:
WITHDRAWN
The Dreamy Jet Study
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Sedation
Blood Drawing Procedure
Eligibility:
All Genders
2-15 years
Phase:
PHASE1
Brief Summary
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. Participa...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Referred to UW Health American Family Children's Hospital Pediatric Sedation Clinic for minimally invasive procedures such as blood draw, IV placement, or immunization
- Age 2-15 years
- Weight \<40kg
Exclusion
- Participants with elevated intracranial pressure
- Participants with uncontrolled hypertension
- Participants who are pregnant or possibly pregnant (i.e., people of child bearing potential unable to provide a negative pregnancy test)
- Participants who received a dose of medication within 2 hours of their appointment with the intention of sedation (i.e., benzodiazepines, opioids, alpha-2 agonists, 1st generation antihistamines)
- Participants who are receiving medications which might enhance the sympathomimetic effect of ketamine (i.e., theophylline, aminophylline, amphetamine, or pseudoephedrine)
- Participants who are receiving medications that might interfere with the expected pharmacokinetics of ketamine (i.e., ketoconazole, clarithromycin, rifampin, or carbamazepine)
- Participant's parent/legal guardian requires a translator for communication about the patient's medical care
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06919198
Start Date
September 1 2025
End Date
August 1 2028
Last Update
August 12 2025
Active Locations (1)
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1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705