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| ID | Type | Description | Link |
|---|---|---|---|
| A536750 | Other Identifier | UW Madison | |
| SMPH\PEDIATRICS\PICU | Other Identifier | UW Madison | |
| Protocol Version 12/20/24 | Other Identifier | UW Madison |
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IND application was not approved
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J-tip jet injection | Experimental | Participants will be given ketamine via J-tip jet injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | ketamine 2.5 mg/kg |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Peters, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Up to 20 minutes |
| Rate of adverse events | Reported as a percentage of total participants who experience an adverse event. | Up to 3 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |