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Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.
Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.15 mg/kg IV Ketamine | Active Comparator |
| |
| 0.3 mg/kg IV Ketamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration | Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score From Baseline to 15 Minutes | Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. | 15 minutes |
| Change in Pain Score From Baseline to 60 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Lovett, MD | Loyola University Chicago, LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Group | 0.15 mg/kg dose of intravenous ketamine |
| FG001 | High Dose Group | 0.3 mg/kg dose of intravenous ketamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.15 mg/kg IV Ketamine | Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes |
| BG001 | 0.3 mg/kg IV Ketamine | Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes |
| 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 | Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration | Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. | Posted | Mean | 95% Confidence Interval | score on a scale | 30 minutes |
|
60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
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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 | 0.15 mg/kg IV Ketamine | Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Experienced feeling of fatigue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Lovett, MD, Associate Professor of Emergency Medicine | Trinity Health, Loyola University Medical Center, Stritch School of Medicine | 7082168705 | slovett@lumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2018 | May 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
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All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
| 60 minutes |
| Number of Participants Who Need Additional Pain Medication at 30 Minutes | Patient request for additional pain medications at 30 minutes post initiation of drug administration | 30 minutes |
| Number of Patients Who Need Rescue Medications at 60 Minutes | Patient request for additional pain medications at 60 minutes | 60 minutes |
| Adverse Effects at 30 Min | Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc. | 30 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Co-morbidities | Number | participants |
|
| Weight | Mean | Inter-Quartile Range | kilograms |
|
| Type of Pain | Count of Participants | Participants |
|
| Duration of Pain | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Pain Score From Baseline to 15 Minutes | Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. | Posted | Mean | 95% Confidence Interval | score on a scale | 15 minutes |
|
|
|
| Secondary | Change in Pain Score From Baseline to 60 Minutes | Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain. | Posted | Mean | 95% Confidence Interval | score on a scale | 60 minutes |
|
|
|
| Secondary | Number of Participants Who Need Additional Pain Medication at 30 Minutes | Patient request for additional pain medications at 30 minutes post initiation of drug administration | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Number of Patients Who Need Rescue Medications at 60 Minutes | Patient request for additional pain medications at 60 minutes | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Adverse Effects at 30 Min | Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc. | Posted | Number | participants | 30 minutes |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 28 |
| 49 |
| EG001 | 0.3 mg/kg IV Ketamine | Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes | 0 | 49 | 0 | 49 | 31 | 49 |
| Dizziness | Nervous system disorders | Systematic Assessment | Feeling dizzy |
|
| Headache | General disorders | Systematic Assessment | Feeling Headache |
|
| Feeling of Unreality | General disorders | Systematic Assessment | Feeling out of body/unreality |
|
| Hearing Changes | Ear and labyrinth disorders | Systematic Assessment |
|
| Vision Changes | Eye disorders | Systematic Assessment |
|
| Mood Alteration | Psychiatric disorders | Systematic Assessment |
|
| Discomfort | General disorders | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Headache |
|
| Feeling of Unreality |
|
| Hearing Changes |
|
| Vision Changes |
|
| Mood Alteration |
|
| Discomfort |
|
| Hallucinations |
|