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| Name | Class |
|---|---|
| United States Air Force Research Laboratory | FED |
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This is a prospective, randomized controlled trial which will be conducted to determine whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with chronic pain syndrome presenting to the emergency department with exacerbation of their chronic pain. The investigators also aim to determine whether use of SDDK can reduce the amount of subsequent opioid pain medications required for adequate pain relief in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo controlled arm |
|
| very low dose ketamine | Experimental | 0.25 mg/kg of sub-dissociative ketamine as an experimental arm |
|
| low dose ketamine | Experimental | 0.50 mg/kg of sub-dissociative ketamine as an experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | sub-dissociative ketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Percentage of Subjects Who Achieved Significant Pain Relief Between the 3 Treatment Groups as Measured by a Visual Analog Pain Scale at 60 Minutes A Decrease of at Least 20 mm on the VAS Will be Considered "Significant" Pain Relief | The primary endpoint was clinically significant pain relief defined a priori as a decrease in the pain VAS of at least 20 mm from baseline, which was arbitrarily chosen as the minimal amount that may be important to this group of patients and was extrapolated from studies of acute pain management in the ED. Using an effect size of 20-mm change in VAS as the marker for a successful outcome and the proportion of successes by group as the analysis point, we performed a power analysis using three groups: 0.5 mg/kg ketamine, 0.25 mg/kg ketamine, and placebo and found that a sample size of 96 subjects would be required to detect a statistically significant difference among groups with a power of 90% (a = 0.05). Expecting a loss of 10% of subjects due to patient withdrawal or incomplete data, 106 subjects were recruited. Only subjects who completed the 60-minute study and had data recorded for each of the time points were included in the analysis. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine | Subjects will be continuously assessed for complications secondary to the sub-dissociative ketamine | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tanen, MD | Los Angeles Biomedical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, Harbor-UCLA Medical Center | Torrance | California | 90501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30901130 | Derived | Lumanauw DD, Youn S, Horeczko T, Yadav K, Tanen DA. Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain. Acad Emerg Med. 2019 Sep;26(9):1044-1051. doi: 10.1111/acem.13755. Epub 2019 Apr 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo controlled arm Placebo: Normal Saline |
| FG001 | Very Low Dose Ketamine | 0.25 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
| FG002 | Low Dose Ketamine | 0.50 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo controlled arm Placebo: Normal Saline |
| BG001 | Very Low Dose Ketamine | 0.25 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | To Compare the Percentage of Subjects Who Achieved Significant Pain Relief Between the 3 Treatment Groups as Measured by a Visual Analog Pain Scale at 60 Minutes A Decrease of at Least 20 mm on the VAS Will be Considered "Significant" Pain Relief | The primary endpoint was clinically significant pain relief defined a priori as a decrease in the pain VAS of at least 20 mm from baseline, which was arbitrarily chosen as the minimal amount that may be important to this group of patients and was extrapolated from studies of acute pain management in the ED. Using an effect size of 20-mm change in VAS as the marker for a successful outcome and the proportion of successes by group as the analysis point, we performed a power analysis using three groups: 0.5 mg/kg ketamine, 0.25 mg/kg ketamine, and placebo and found that a sample size of 96 subjects would be required to detect a statistically significant difference among groups with a power of 90% (a = 0.05). Expecting a loss of 10% of subjects due to patient withdrawal or incomplete data, 106 subjects were recruited. Only subjects who completed the 60-minute study and had data recorded for each of the time points were included in the analysis. | Posted | Count of Participants | Participants | 60 minutes |
Up to 48 hours after study enrollment
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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 | Placebo | placebo controlled arm Placebo: Normal Saline | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Patients self-reported feeling nauseated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Tanen | Lundquist Institute | 310-222-3624 | dtanen@emedharbor.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 | May 16, 2018 | Aug 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Normal Saline |
|
|
| Did not meet inclusion criteria |
|
| BG002 | Low Dose Ketamine | 0.50 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Pain as measured by validated Visualized Analog Scale (0 to 100 mm) | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | placebo controlled arm Placebo: Normal Saline |
| OG001 | Very Low Dose Ketamine | 0.25 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
| OG002 | Low Dose Ketamine | 0.50 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine |
|
|
| Secondary | Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine | Subjects will be continuously assessed for complications secondary to the sub-dissociative ketamine | Posted | Number | recorded adverse events | 1 hour |
|
|
|
| Post-Hoc | Follow-up Pain Scores Obtained by Telephone at 24 - 48 Hours | Subjects were contacted by phone 24 - 48 hours after the completion of the study infusion. Subjects were asked to score their pain on 10-point numeric rating scale where 0 represented no pain and 10 represented the worst pain they could be having. Pain score was recorded in increments of 1 from 0 - 10. Results were compared between groups using the Mann-Whitney U-test. | Posted | Median | Inter-Quartile Range | units on a scale | 24 - 48 hours after study drug infusion |
|
|
|
| 32 |
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Very Low Dose Ketamine | 0.25 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine | 0 | 35 | 14 | 35 | 0 | 35 |
| EG002 | Low Dose Ketamine | 0.50 mg/kg of sub-dissociative ketamine as an experimental arm Ketamine: sub-dissociative ketamine | 0 | 30 | 12 | 30 | 0 | 30 |
|
| Dizziness | Nervous system disorders | Systematic Assessment | Subjects were asked if they felt "dizzy" |
|
| Hallucinations | Nervous system disorders | Systematic Assessment | Subjects were assessed for hallucinations |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Anxiety and Dizziness | Nervous system disorders | Systematic Assessment |
|
| Anxiety and Palpitations | Nervous system disorders | Systematic Assessment |
|
| Dysphoria | Nervous system disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Male |
|