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| ID | Type | Description | Link |
|---|---|---|---|
| University of Iowa |
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lack of enrollment
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The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Ketamine | Experimental |
| |
| Intramuscular Ketamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Intranasal Ketamine (100 mg/mL) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Sedation | Minutes it takes until the patient is cooperative enough for the procedure | Every 60 seconds through study completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hogrefe, MD | University of Iowa | Principal Investigator |
| Brett Faine, Pharm.D. | University of Iowa | Principal Investigator |
| Andrew Nugent, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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6 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Ketamine | Enrolled 2 patients over 6 month period |
| FG001 | Intramuscular Ketamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Ketamine | |
| BG001 | Intramuscular Ketamine | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Onset of Sedation | Minutes it takes until the patient is cooperative enough for the procedure | Posted | Count of Participants | Participants | Every 60 seconds through study completion |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Ketamine | None Reported |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Faine | University of Iowa | 319-310-8067 | brett-faine@uiowa.edu |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine |
| Drug |
Intramuscular Ketamine |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Intramuscular Ketamine | None report | 0 | 1 | 0 | 1 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |