The Dreamy Jet Study

Phase 1

Not yet recruiting

• Conditions: Sedation; Blood Drawing Procedure; Immunization; IV Placement
• Interventions: Drug: Ketamine

• Registration Number: NCT06919198
• Lead Sponsor: University of Wisconsin, Madison

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.

Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.

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 clinic environment. Minimally invasive procedures include, but are not limited to, blood draws, IV placement, and immunizations.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-07
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
J-tip jet injection	Ketamine	Participants will be given ketamine via J-tip jet injection

Primary Outcome Measures

Name	Time	Method
Feasibility of procedural success	Up to 3 hours	Feasibility is measured by completion of the procedure using only the study drug. It is indicated by "yes" or "no".

Secondary Outcome Measures

Name	Time	Method
Rate of procedural success	Up to 3 hours	Percentage of participants who are able to complete the procedure using only the study intervention.
Time it takes to achieve target PSSS score	Up to 20 minutes	Time to PSSS score is measured from time of injection until target PSSS is achieved.
Rate of adverse events	Up to 3 hours	Reported as a percentage of total participants who experience an adverse event.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States