The Dreamy Jet Study

NCT06919198 | Withdrawn Phase 1 DMC FDA Drug

• 4 other identifiers: 2024-1429A536750SMPH\PEDIATRICS\PICUProtocol Version 12/20/24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Blood Drawing Procedure; Immunization; IV Placement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of procedural success

  Up to 3 hours

• Time it takes to achieve target PSSS score

  Up to 20 minutes

• Rate of adverse events

  Up to 3 hours

Study Arms (1)

J-tip jet injection

EXPERIMENTAL

Participants will be given ketamine via J-tip jet injection

Drug: Ketamine

Interventions

Ketamine DRUG

ketamine 2.5 mg/kg

J-tip jet injection

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Megan Peters, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)