Blood Drawing Procedure, Immunization, IV Placement, Sedation
Conditions
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.
Interventions
DRUGKetamine
ketamine 2.5 mg/kg
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed