The Dreamy Jet Study

Phase 1WithdrawnNCT06919198

University of Wisconsin, Madison

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Sedation Blood Drawing Procedure Immunization IV Placement

Interventions

KetamineDRUG

ketamine 2.5 mg/kg

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Feasibility of procedural success

Feasibility is measured by completion of the procedure using only the study drug. It is indicated by "yes" or "no".

Time frame: Up to 3 hours

Secondary Outcomes

Rate of procedural success

Percentage of participants who are able to complete the procedure using only the study intervention.

Time frame: 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.

Time frame: Up to 20 minutes

Rate of adverse events

Reported as a percentage of total participants who experience an adverse event.

Time frame: Up to 3 hours

Data from ClinicalTrials.gov

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