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This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous ketamine | Active Comparator | Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. |
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| Intranasal ketamine | Experimental | Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ketamine | Drug | Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Adequate Sedation. | Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation. | Induction up to 10 minutes |
| Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications. | From induction to discharge from sedation by emergency physician, up to 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Non-serious Adverse Events. | Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations. | From induction to discharge from the emergency department. |
| Duration of Sedation Using Modified Ramsay Sedation Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Statler, MD | Emory University | Study Chair |
| Judson Barber, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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Patient screening, enrollment and informed consent will be obtained in the emergency department (ED) of Children's of Alabama (COA). Data collection will take place in the ED as well as in Children's Park Place, Suite 110. The remainder of the research, including data analysis, and collaboration amongst the principal investigator and the sub-investigators, will be conducted in Children's Park Place, Suite 110.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Ketamine | Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 2, 2021 |
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| Intranasal Ketamine | Drug | Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
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Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation. |
| From induction to discharge from sedation by the emergency physician. |
| Duration of Emergency Department Stay. | Measured from time of arrival to emergency department to discharge order. | From arrival to emergency department to discharge order entered by emergency physician. |
| FG001 | Intranasal Ketamine | Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Ketamine | Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
| BG001 | Intranasal Ketamine | Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Allergies | Whether participants have any previous known medication allergies. | Count of Participants | Participants |
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| Weight (kg) | Mean | Standard Deviation | weight in kilograms |
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| Past Medical History | Whether participants have any known previous medical history. | Count of Participants | Participants |
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| Past Surgical History | Whether participants have any previous surgical history. | Count of Participants | Participants |
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| 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 | Number of Participants Who Achieved Adequate Sedation. | Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation. | Posted | Count of Participants | Participants | Induction up to 10 minutes |
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| Primary | Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications. | Number of participants that required rescue dosing either due to inadequate sedation at 10 minutes or after adequate sedation at 10 minutes but requiring more sedation to complete the procedure. | Posted | Count of Participants | Participants | From induction to discharge from sedation by emergency physician, up to 3 hours. |
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| Secondary | Percentage of Participants With Non-serious Adverse Events. | Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations. | Percentage of participants that experienced any possible adverse events from sedation with either intravenous or intranasal ketamine. | Posted | Count of Participants | Participants | From induction to discharge from the emergency department. |
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| Secondary | Duration of Sedation Using Modified Ramsay Sedation Scale. | Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation. | Describes the duration of sedation (in minutes) from the start of induction to when participant was discharged from sedation by the emergency physician. | Posted | Mean | Standard Deviation | Minutes | From induction to discharge from sedation by the emergency physician. |
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| Secondary | Duration of Emergency Department Stay. | Measured from time of arrival to emergency department to discharge order. | Duration of total emergency department stay from arrival to the emergency department to discharge order entered by emergency physician. | Posted | Mean | Standard Deviation | Time (in minutes) | From arrival to emergency department to discharge order entered by emergency physician. |
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From the time the induction medication (either intranasal ketamine or intranasal hypertonic saline) to discharge order by the emergency physician, up to 6 hours.
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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 | Intravenous Ketamine | Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | 0 | 17 | 0 | 17 | 1 | 17 |
| EG001 | Intranasal Ketamine | Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | 0 | 23 | 0 | 23 | 3 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting after the conclusion of the sedation and procedure not including nausea. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Statler, MD | University of Alabama at Birmingham, Department of Pediatrics | (205) 638-6048 | jstatler@uabmc.edu |
| Mar 3, 2023 |
| Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005596 | Fractures, Closed |
| D050723 | Fractures, Bone |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| No |
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| No |
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