WithdrawnPhase 1ketamine

The Dreamy Jet Study

Sponsored by University of Wisconsin, Madison

NCT ID
NCT06919198
Start Date
2025-09
Est. Completion
2028-08

About This Study

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.

Conditions Studied

SedationBlood Drawing ProcedureImmunizationIV Placement

Interventions

  • Ketamine

Eligibility

Age:2 Years - 15 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Study Locations (1)

University of Wisconsin - Madison
Madison, Wisconsin, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source