The Dreamy Jet Study

University of Wisconsin (UW)

Status and phase: Withdrawn; Phase 1

Conditions: IV Placement; Immunization; Blood Drawing Procedure; Sedation

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06919198

2024-1429

Protocol Version 12/20/24 (Other Identifier)

SMPH\PEDIATRICS\PICU (Other Identifier)

A536750 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

J-tip jet injection

Experimental group

Description:

Participants will be given ketamine via J-tip jet injection

Treatment:

Drug: Ketamine