The Dreamy Jet Study

Procedural Sedation for Minor Procedures Using Jet-Injected Subcutaneous Ketamine

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.

Study Overview

• Status: Withdrawn
• Conditions: Sedation; Immunization; Blood Drawing Procedure; IV Placement
• Intervention / Treatment: Drug: Ketamine

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: J-tip jet injection; Participants will be given ketamine via J-tip jet injection	Drug: Ketamine; ketamine 2.5 mg/kg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of procedural success	Percentage of participants who are able to complete the procedure using only the study intervention.	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.	Up to 20 minutes
Rate of adverse events	Reported as a percentage of total participants who experience an adverse event.	Up to 3 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Megan Peters, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Ketamine
• Other Study ID Numbers: 2024-1429; SMPH\PEDIATRICS\PICU (Other Identifier: UW Madison); Protocol Version 12/20/24 (Other Identifier: UW Madison); A536750 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No